[Faith-talk] Fwd: Harvard Sleep Study! From: Lorine W. Calhoun, from chr. (323) 299-8620

[eric calhoun]

--- atthetopoflife at aol.com wrote:

> To: chargerdodger at yahoo.com
> Subject: Fwd: Harvard Sleep Study!  From: Lorine W.
> Calhoun, from chr.  (323)
>  299-8620
> Date: Mon, 12 Nov 2007 20:34:19 -0500
> From: atthetopoflife at aol.com
> 
> 
> 
> 
> 
> 
> 
> -----Original Message-----
> From: atthetopoflife at aol.com
> To: sherrynmarie at Yahoo.com
> Sent: Sun, 11 Nov 2007 6:20 pm
> Subject: Fwd: Harvard Sleep Study! From: Lorine W.
> Calhoun, from chr. (323) 299-8620
> 
> 
> 
> 
> 
> 
> Hello Lorine,
> Thank you for your inquiry.  This email is pretty
> long, but it contains a lot of information (below)
> regarding the research study. Please read it over
> carefully and let me know if you have any
> questions.  The first section provides general
> information regarding the study from the study
> project leader Joseph Hull. Below the general
> information is a questionnaire and then below the
> questionnaire is a study description with more
> details about the inpatient portion of the study.
> Thank you again for your interest in our Sleep
> Research Study.
> 
> Best regards,
> 
> Tess Cooper
> 
> Research Assistant IÂ Â Â Â Â Â Â Â Â Â 
> Â Â Â Â Â Â Â Â Â Â Â Â Â Â  
> Division of Sleep Medicine
> Brigham and Women's Hospital
> 221 Longwood Avenue, BLI-425
> Boston, MA 02115Â  USA
> Phone: 1-1888-828-4294
> Email: tcooper at rics.bwh.harvard.edu
> 
> 
> GENERAL INFORMATION REGARDING PROTOCOL TITLED,
> "PHOTIC AND NONPHOTIC INPUT TO THE HUMAN CIRCADIAN
> SYSTEM:"
> 
> Â Â Â Â Â Â Â  Thank you for your inquiry about the
> research study that we are conducting here in
> Boston.  First, I should introduce myself. My name
> is, Joseph Hull. I am a co-investigator of the study
> working with Dr. Charles A. Czeisler, Ph.D., M.D.
> and Dr. Steven W. Lockley, Ph.D. at the Division of
> Sleep Medicine, Harvard Medical School, Brigham and
> Women's Hospital in Boston, MA.  We are currently
> conducting research to better understand the nature
> of human sleep and circadian rhythms (i.e., the
> human body clock) in blind individuals with no
> conscious light perception, as well as understanding
> how the loss of light perception affects the human
> body clock. This research will also increase our
> knowledge on how the loss of light perception
> affects the human body clock in daily life. We are
> looking for healthy participants who have no light
> perception, do not have any current medical problems
> or take any prescription medications.  The duration
> of this study is approximately 3-5 consecutive
> months   Individuals who are interested and are
> willing to participate must first go through health
> screening to determine your eligibility. During the
> duration of the screening process, we will ask you
> to record daily sleep diaries, collect urine samples
> for a 48 h period each week, and wear a wrist-watch
> that monitors and records the surrounding light
> levels and your motor activity.  If your screening
> results that you are healthy and meet our study
> criteria, and you provide written consent to
> participate, you will then be eligible to
> participate in the study. You will be asked to
> participate in a three-part study.  During part 1
> of the study, we ask you to live in our lab for 6
> days.  As a research subject you will be asked to
> refrain from any drug use, including alcohol,
> caffeine, nicotine, over-the-counter medications,
> narcotics, etc. After completing part 1 of the study
> you will return home for part 2 of the study. During
> part 2 of the study, we will again ask you to keep
> daily sleep diaries, collect urine samples and wear
> a wrist-watch that records light levels and your
> motor activity for up to eight to sixteen weeks. 
> Throughout your home-based study we may also ask you
> to keep a regular 8-hour time in bed schedule. After
> completing part 2 of the study, you will then be
> asked to live again at our laboratory for either 15
> or 28 days.  The duration of your second visit will
> be decided by the results obtained during part 1 of
> the study.  We will arrange and pay for your
> transportation, including flights to and from Boston
> and any other costs associated with your
> participation.  We will try to accommodate the
> start dates to fit into your schedule as best as
> possible, however we may need to schedule your
> second inpatient visit on particular date.  You
> will be compensated for your time spent in the
> laboratory and also for completing particular study
> procedures.  Depending on the total duration of
> your individual study, you could receive up to
> $9,300.00 for your participation.
> During your inpatient visit, you will in our sleep
> laboratory at the Brigham and Women's Hospital in
> Boston.  You will live continuously in your own
> room for the duration of the 6 and 15 or 28-day
> inpatient studies (24/7).  There are frequent,
> daily interactions with myself, research technicians
> and nurses while in you live in the lab, however
> during your inpatient visits we remove all
> indications of clock time or time of day. 
> Therefore the following items are not permitted in
> the room: clocks, watches, cell phones, any devices
> with a clock (i.e., mp3 players or digital
> recorders), telephones, internet, and live radio or
> live TV.  Personal visitors are not permitted
> during the inpatient visits, but you may receive
> email, mail and newspapers (cd-version) through the
> investigator or study coordinator.  Unfortunately,
> due to the nature of the research guide dogs are not
> permitted in the rooms during inpatient visits,
> however we will pay the cost for your guide dogs
> care in your absence, if necessary.  The room is
> equipped with a laptop computer (JAWS) for personal
> use, a CD players, a VCR, Braille writer and 4-track
> players for your use during the study.
> To begin screening for this study you will need to
> fill-out our initial questionnaire. This
> questionnaire will help us determine whether you are
> eligible to screen for participation in this
> study.  If you are eligible to screen for this
> study, you will need to complete the following
> screening procedures, in the order indicated, before
> you are actually eligible to participate: #1. You
> will need to give us written consent to screen you
> for this study by signing a formal screening consent
> form; #2. You will need to fill out six screening
> forms and questionnaires; #3. You will need to have
> an interview with our psychologist over the phone;
> #4. You will need to schedule a physical with your
> doctor or one of ours in Boston if possible. If you
> are found eligible based on the results of your
> screening forms, physical exam and psychological
> evaluation, you will need to have a comprehensive
> eye exam with our neuro-ophthalmologist here in
> Boston.  In addition, you will need to review
> another research consent form with myself and
> another study representative, which we will be
> performed either in person or over the phone. 
> During this review session we will formally disclose
> the study procedures and what procedures we are
> asking you to perform during your participation. 
> If at this point you do not wish to participate you
> can withdraw your consent. However, you may withdraw
> your consent at any time during the study.  Signing
> either the screening consent form or the research
> consent form does not obligate you to screen,
> participate or complete this study.  Your signature
> only provides us with your written consent to start
> the screening and/or study procedures.  Your
> signature also indicates that we have informed you
> of all procedures, as well as the possible risks and
> benefits that accompany your participation.  You
> may ask questions at any time, and you may request
> counsel with one of our physicians regarding any
> medical or health concerns, issues or questions
> related to the study. Again, if you have any
> questions please feel free to contact me.  I have
> attached a copy of the initial questionnaire.  I,
> or my assistant, can also provide further details
> regarding procedures during inpatient visits as well
> as go over the initial questionnaire with you over
> the phone at a later date should you decide you
> would like to proceed.  Thank you for your time.
> Best regards,
> Joseph Hull
> Project Leader
> Division of Sleep Medicine
> Brigham and Women's Hospital
> 221 Longwood Avenue, BLI-438
> Boston, MA 02115Â  USA
> Phone: 1-888-828-4294
> Email: jhull at partners.org
> 
> 
> 
> THE FOLLOWING IS THE INITIAL QUESTIONNAIRE:
> Type your answers at the end of the question OR
> after the colon. You can mail or email this back to
> me.  Please be advised that e-mail is an unsecured
> median. If you do not wish to email sensitive
> information over e-mail please make arrangements to
> send via U.S. Post or your native postal carrier.
> 
> *Any personal and identifying information asked
> during this phone screen will need to be stored in
> the Division of Sleep Medicine Database. Do you give
> us permission to enter contact information in our
> Database? Yes or no?
> *If you are found ineligible, or are uninterested in
> this particular study, would you like to be informed
> about other studies in the future? Yes or no?
> 
> #1. Please give today's date:
> 
> #2. Please give your FIRST name ONLY:
> 
> #3. Please give your Email address:
> 
> #4. Please give your Phone number:
> 
> #5. Please give your Address:
> 
> #6. Please give your age and date of birth:
> 
> #7. How did you hear about the study?
> 
> #8. Have you ever done a research study before? If
> so, can you give details?
> 
> #9. Are you totally blind in both eyes?
> 
> #10. Do you have any conscious light perception in
> either eye?
> 
> #11. At what age and/or what year did you become
> totally blind in both eyes?
> 
> #12. What is the cause of your total blindness (if
> known)?
> 
> #13. Have one or both of your eyes been enucleated
> (removed)?
> 
> #14. Do you wear sunglasses, cosmetic scleral eye
> shells, or any type of protective eyewear?  Please
> explain?
> 
> #15. What is your height?
> 
> #16. What is your weight?
> 
> #17. Do you have any current medical illnesses or
> problems (if so please describe)? If female, are you
> currently pregnant?
> 
> #18. Do you have problems with your sleep (if so
> please describe)?
> 
> #19. Have you ever or do you currently use any
> sleeping pills?
> 
> #20. What is your usual wake time?
> 
> #21. Do you get up at a different time on some days?
> If so, when and why?
> 
> #22. What is your usual bedtime?
> 
> #23. Do you wake up in the night? If so how often,
> how long each time, why do you wake?
> 
> #24. Do you nap during the day? If so, how often do
> you nap, how long is your nap?
> 
> #25. Do you ever fall asleep without meaning to?
> 
> #26. Have you ever done night work or rotating shift
> work?
> 
> #27. If so, for each job how many days per week did
> you work nights, what were your work hours? For each
> job list what months and years you started and
> ended:
> 
> #28. Have you ever traveled to a different time
> zone? Where did you go? When did you come back?
> 
> The next set of questions will ask you about your
> past or current state of health. Please answer yes
> or no after the question mark. If you answer yes to
> any of the following medical issues below, please
> describe details, e.g., provide diagnosis, what
> treatment was given, is the condition ongoing?
> 
> #29. Have you had, or do you currently have heart or
> cardiovascular disease?
> 
> #30. Have you had, or do you currently have a heart
> murmur?
> 
> #31. Have you had, or do you currently have high
> blood pressure (also called hypertension)?
> 
> #32. Have you had, or do you currently have any
> endocrine disorders (such as thyroid disease)?
> 
> #33. Have you had, or do you currently have
> hepatitis?
> 
> #34. Have you ever received a hepatitis vaccination?
> 
> #35. Have you had, or do you currently have Asthma
> (what type of inhaler do you use)?
> 
> #36. Have you ever experienced Latex Sensitivity (if
> yes, what physical reaction did you experience?)?
> 
> #37. Have you had, or do you currently have Lung
> disease? (such as emphysema, chronic bronchitis,
> asthma)?
> 
> #38. Have you had, or do you currently have Kidney
> disease? (such as kidney failure, kidney infection,
> kidney stones)?
> 
> #39. Have you had, or do you currently have a
> Neurological disorder? (such as epilepsy, stroke,
> amnesia, migraine headaches, Parkinson's disease)?
> 
> #40. Have you ever suffered a head injury or loss of
> consciousness?
> 
> #41. Do you have Diabetes? (type 1 or type 2?)
> 
> #42. Have you had, or do you currently have a
> stomach or intestinal/digestive disorder? (such as
> ulcer, gastritis, gall bladder problems)?
> 
> #43. Do you have any hearing impairments?
> 
> #44. Have you ever received any psychiatric care or
> counseling?
> 
> #45. Have you ever been prescribed a medication from
> a psychiatrist?
> 
> #46. Do you have any family history of mental
> illness?
> 
> #47. Do you have any history of attempted suicide by
> yourself or a family member?
> 
> #48. Have you ever had any minor or major surgery?
> (What? When? Why?)
> 
> #49. Are you currently taking any of the following
> medications listed below? Please answer yes or no
> after the colon.
> Heart pill:
> Water pill (diuretic):
> Laxative:
> Sedatives (valium):
> Breathing pill:
> Sleeping pill:
> Health food supplement or herbal remedy (if so, what
> kind and what is it?):
> Pain pills, such as aspirin, Tylenol, Motrin (if so,
> why?):
> Circulation/blood pill:
> Antacid:
> Antihistamine:
> Birth control pill (female); if so what kind/brand:
> Acne medication:
> Any other pills, remedies or medications not
> mentioned? If so, what kind?:
> 
> #50. Do you currently or have you in the past used
> any of the following listed below? If yes, please
> describe details (when last used, how frequently)?
> 
> Marijuana:
> cocaine:
> amphetamines:
> Ecstasy:
> LSD, Mushrooms:
> Steroids (like D H E A, or Andro):
> cigarettes (if yes, how many per day?):
> Chewing tobacco:
> Cigars:
> Patches:
> 
> #51. How much coffee do you drink per day, per week,
> per month, or per year (whichever is the most
> common)?
> 
> #52. How much tea do you drink per day, per week,
> per month, or per year (whichever is the most
> common)?
> 
> #53. How many caffeinated soft drinks do you drink
> per day, per week, per month, or per year (whichever
> is the most common)?
> 
> #54. How much chocolate do you eat, or drink per
> day, per week, per month, or per year (whichever is
> the most common)?
> 
> #55. How many alcoholic drinks do you drink (please
> specify type, such as beer, wine, liquor, etc.) per
> day, per week, per month, or per year (whichever is
> the most common)?
> 
> You have now completed the initial questionnaire;
> thank you for your time.
> 
> 
> Study Description
> The following is the study description for a
> three-part study.
> Part 1: A 6-day study while you live in our
> laboratory
> Part 2: An 8 to16 week study while you live at home
> Part 3: A 15 or 28-day study while you live in
> laboratory
> Study Coordinator: Joseph Hull
> jhull at partners.org
> 
> We are currently seeking healthy, totally blind men
> and women ages 18-70 to participate in a home and
> laboratory research study.  The study consists of
> two laboratory visits that are separated by an eight
> to sixteen week home-based field study.  The
> purpose of this study is to increase knowledge about
> the human biological clock.  The knowledge gained
> from this study may improve the health, productivity
> and safety of not only totally blind individuals,
> but also those with a high prevalence of insomnia,
> such as shift workers and the elderly.
> 
> Prior to entering the study we will ask you to
> complete a screening process, which involves filling
> out screening forms, having a physical exam with a
> physician, blood and urine tests, having an
> ophthalmological eye exam and completing an
> assessment with our staff  psychologist.  The
> screening can be completed in up to three to five
> visits.
> 
> In order for the study to achieve the highest
> quality results you will be asked to participate in
> both a home-based outpatient protocol and two
> inpatient protocols, which will require two visits
> to the hospital.  You will first remain in the
> hospital for your inpatient visit #1 for the
> duration of 6 days.  Upon completing the initial 6
> days, you will return home for an 8 to 16-week
> home-based outpatient protocol.  The length of your
> home-based protocol will be determined in the first
> few weeks after starting home-based protocol. Upon
> completing the home-based protocol, you will return
> to the hospital for your inpatient visit #2.  Your
> inpatient visit #2 will be either 15 or 28 days in
> duration.  The length of your inpatient visit #2
> will be determined by the results obtained during
> inpatient visit #1.  During each inpatient visit,
> we will request that you not leave your suite until
> the completion of the inpatient protocol.  This is
> unless you choose to withdraw from the study, which
> is your option at any point (see payment section
> below).
> 
> Inpatient Study Conditions
> Environment free of time cues:Â  The study seeks to
> create an environment free of time cues.  Anything
> that might give study participants a time cue is
> prohibited.  This means that there are no windows
> in your suite as well as no watches, clocks, live
> TV’s, radios, phone calls or visitors, although
> you will have frequent interaction with the research
> staff and you are able to listen to tapes and
> CD’s.
> 
> Constant Routines: For 3 to 5 times during the study
> you will be asked to participate in a procedure
> called a constant routine. This procedure will
> require you to remain in bed, awake, and relatively
> inactive for up to 20-70 hours. You will be given
> the opportunity to sleep between these periods of
> extended wakefulness. We will monitor your brain
> waves continuously during these constant routines,
> and proportioned snacks will be provided
> periodically, such that your overall daily caloric
> intake will equal the amount you would receive in
> three meals and a snack.
> 
> Constant Posture: On as many as 2 occasions during a
> visit#2 inpatient protocols you will be asked to
> participate in a procedure called a constant posture
> protocol. This procedure will require you to remain
> relatively inactive while in bed and for up to 40
> hours, but you will be given an opportunity to sleep
> during this time.. We will monitor your brain waves
> continuously during these constant postures, and
> three meals and a snack will be provided before and
> after the sleep opportunity.
> 
> Cognitive Performance Battery: During the study you
> will frequently take a variety of auditory
> performance tests. The tests are presented on a
> computer. You respond to these tests by using the
> keys on a computer keyboard or a two-button response
> pad. The performance tests are of several types and
> test for reaction time, memory, simple math skills
> and your current mood and alertness.
> 
> 
> Free Time:Â  During the study you will have
> significant amounts of free time during which you
> may read, write, listen to music and even play
> musical instruments. However, no exercise other than
> light stretching will be permitted because it
> releases stress hormones into your blood stream and
> elevates body temperature, and this could affect the
> results of our data.
> 
> What We Monitor
> 
> For approximately two weeks prior to entering the
> study for inpatient visit #1 until the completion of
> the study, your sleeping pattern will be
> monitored.  You will wear a wrist activity recorder
> (called an Actiwatch), which measures your activity
> and movement during the day and night. While wearing
> the watch you will be asked to come to the
> recruiting office to have your activity information
> downloaded into our files.  If you live outside the
> Boston area, arrangements will be made for you to
> send back and receive Actiwatches at no cost to you.
> You will also need to keep a logbook at home
> regarding your sleep/wake schedule every morning and
> night.
> 
> 
> During the study the following will be performed:
> Â -Electroencephalogram (EEG): Every night and day
> during scheduled sleep and wakefulness your
> brainwaves will be recorded with an EEG.  Just
> before you go to sleep, you will be asked to wash
> your face with special soap and cleanse the skin
> with an alcohol swab.  Small electrodes will be
> placed on the skin of your scalp, face and chin. 
> These are held in place with special glue that can
> be removed with shampoo.  It is not invasive and
> you do not need to cut or shave your hair for the
> study.  After your scheduled waketimes on non-CR
> days you will have the opportunity shower where
> after you will have electrodes reapplied in a
> similar fashion.
> 
> -Temperature:Â  Your body temperature is monitored
> throughout the study.  This is done using a small
> rectal temperature sensor. This sensor is a very
> thin flexible piece of wire coated in plastic, which
> you would insert and remove yourself. You will be
> asked to remove it for showers and bowel
> movements.  There is tape that marks off the max
> insertion length (~10cm); technicians will
> periodically ask you to check that the sensor is
> inserted up to the tape (alcohol wipes will be
> available).
> 
> -Blood Drawings:Â  During both inpatient visits you
> will have an IV catheter inserted into your
> forearm.  It will remain in your arm for blood
> drawings at various times during both sleep and wake
> periods. The total amount of blood that will be
> taken over the course of the study, including blood
> samples drawn during your screening physical exam
> and inpatient visit’s #1 and # 2 will be
> approximately 32 ounces (approximately 2 pints). A
> very small amount of heparin (an anti-coagulant)
> will run through the IV to prevent clotting in the
> tube.
> 
> -Saliva Samples: During several segments of the
> study we will ask you to emit a small amount of
> saliva from your mouth into a test tube so that we
> can collect salivary hormone
> samples.          
> 
> -Urine Samples: Throughout the entire study urine
> will be collected at frequent times. This allows us
> to monitor specific hormones in your systems. 
> Technicians will ask you periodically to empty your
> bladder; we ask that you try even if you feel that
> you do not have to go.
> 
> Restrictions:Â  The following substances are
> prohibited for the duration of the study, starting
> at the beginning of the screening process until
> completion of the study:
> v     Alcohol
> v     Caffeine Products (coffee, tea,
> soft-drinks, chocolate)
> v     Nicotine
> v     Prescription or non-prescription (over the
> counter) drugs i.e. patches, vitamins, or steroidal
> creams
> v     Poppy seeds
> v     Recreational or Street Drugs
> v     Other foreign substances
> v     Food other that that provided by our
> dietary staff (while in the actual study)
> Â *If in doubt about a particular substance, please
> ask before taking it.
> 
> Payment for participation:
> Physical exam:Â  $25 one time
> Eye exam:Â  $25 one time
> Diaries:Â  $25/week
> Wearing Actiwatch:Â  $25/week
> 48 h Urine collection (Home-based):Â  $25/ 24-hour
> collection at home
> Returning all actiwatches:Â  $25 last return
> In-study at the hospital:Â  $150/day
> Completion bonus:Â  $250/week inpatient stay
> (pro-rated)
> Total = up to $9,300.00
> 
> Payment is in the form of one check 4 weeks after
> completion of the study.
> 
> If the entire study is not completed for any reason,
> subjects are paid for their participation up through
> their last day, but none of the $250/week completion
> bonus is paid.  Also, there is no monetary
> compensation paid to any subject whose blood and/ or
> urine tests indicate use of drugs, alcohol,
> caffeine, nicotine, non-approved prescription or
> over the counter drugs, recreation/street drugs,
> illicit drugs or any other foreign substances.
> 
> Other Benefits
> Although there may be no direct benefit to you from
> participating in this study, we will make known to
> you, upon conclusion and analysis of the data, the
> information gathered from the testing.  There is
> also the chance that the pre-study screening or
> various blood and urine samples taken during the
> study will reveal some medical abnormality.  This
> information will be conveyed to you at once,
> together with a recommendation to a local clinic or
> physician.
> 
> Â 
> 
> Â 
> 
> Â 
> 
> Tess Cooper
> 
> Research Assistant
> 
> Division of Sleep Medicine
> 
> Brigham and Women's Hospital
> 
> 221 Longwood Avenue
> 
> Room #425
> 
> Boston, MA 02115
> 
> phone (617) 525-8412
> 
> fax (617) 582-6006
> 
> tcooper at rics.bwh.harvard.edu
> 
> Â 
> 
> Â 
> 
> Â 
> 
> 
> The information transmitted in this electronic
> communication is intended only for the person or
> entity to whom it is addressed and may contain
> confidential and/or privileged material. Any review,
> retransmission, dissemination or other use of or
> taking of any action in reliance upon this
> information by persons or entities other than the
> intended recipient is prohibited. If you received
> this information in error, please contact the
> Compliance HelpLine at 800-856-1983 and properly
> dispose of this information.
> 
> 
> 
> 
> -----Original Message-----
> From: Tess Cooper <tcooper at rics.bwh.harvard.edu>
> To: atthetopoflife at aol.com
> Sent: Thu, 8 Nov 2007 8:00 am
> Subject: Harvard Sleep Study!
> 
> 
> 
> 
> Hello Lorine,
> Thank you for your inquiry.  This email is pretty
> long, but it contains a lot of information (below)
> regarding the research study. Please read it over
> carefully and let me know if you have any
> questions.  The first section provides general
> information regarding the study from the study
> project leader Joseph Hull. Below the general
> information is a questionnaire and then below the
> questionnaire is a study description with more
> details about the inpatient portion of the study.
> Thank you again for your interest in our Sleep
> Research Study.
> 
> Best regards,
> 
> Tess Cooper
> 
> Research Assistant IÂ Â Â Â Â Â Â Â Â Â 
> Â Â Â Â Â Â Â Â Â Â Â Â Â Â  
> Division of Sleep Medicine
> Brigham and Women's Hospital
> 221 Longwood Avenue, BLI-425
> Boston, MA 02115Â  USA
> Phone: 1-1888-828-4294
> Email: tcooper at rics.bwh.harvard.edu
> 
> 
> GENERAL INFORMATION REGARDING PROTOCOL TITLED,
> "PHOTIC AND NONPHOTIC INPUT TO THE HUMAN CIRCADIAN
> SYSTEM:"
> 
> Â Â Â Â Â Â Â  Thank you for your inquiry about the
> research study that we are conducting here in
> Boston.  First, I should introduce myself. My name
> is, Joseph Hull. I am a co-investigator of the study
> working with Dr. Charles A. Czeisler, Ph.D., M.D.
> and Dr. Steven W. Lockley, Ph.D. at the Division of
> Sleep Medicine, Harvard Medical School, Brigham and
> Women's Hospital in Boston, MA.  We are currently
> conducting research to better understand the nature
> of human sleep and circadian rhythms (i.e., the
> human body clock) in blind individuals with no
> conscious light perception, as well as understanding
> how the loss of light perception affects the human
> body clock. This research will also increase our
> knowledge on how the loss of light perception
> affects the human body clock in daily life. We are
> looking for healthy participants who have no light
> perception, do not have any current medical problems
> or take any prescription medications.  The duration
> of this study is approximately 3-5 consecutive
> months   Individuals who are interested and are
> willing to participate must first go through health
> screening to determine your eligibility. During the
> duration of the screening process, we will ask you
> to record daily sleep diaries, collect urine samples
> for a 48 h period each week, and wear a wrist-watch
> that monitors and records the surrounding light
> levels and your motor activity.  If your screening
> results that you are healthy and meet our study
> criteria, and you provide written consent to
> participate, you will then be eligible to
> participate in the study. You will be asked to
> participate in a three-part study.  During part 1
> of the study, we ask you to live in our lab for 6
> days.  As a research subject you will be asked to
> refrain from any drug use, including alcohol,
> caffeine, nicotine, over-the-counter medications,
> narcotics, etc. After completing part 1 of the study
> you will return home for part 2 of the study. During
> part 2 of the study, we will again ask you to keep
> daily sleep diaries, collect urine samples and wear
> a wrist-watch that records light levels and your
> motor activity for up to eight to sixteen weeks. 
> Throughout your home-based study we may also ask you
> to keep a regular 8-hour time in bed schedule. After
> completing part 2 of the study, you will then be
> asked to live again at our laboratory for either 15
> or 28 days.  The duration of your second visit will
> be decided by the results obtained during part 1 of
> the study.  We will arrange and pay for your
> transportation, including flights to and from Boston
> and any other costs associated with your
> participation.  We will try to accommodate the
> start dates to fit into your schedule as best as
> possible, however we may need to schedule your
> second inpatient visit on particular date.  You
> will be compensated for your time spent in the
> laboratory and also for completing particular study
> procedures.  Depending on the total duration of
> your individual study, you could receive up to
> $9,300.00 for your participation.
> During your inpatient visit, you will in our sleep
> laboratory at the Brigham and Women's Hospital in
> Boston.  You will live continuously in your own
> room for the duration of the 6 and 15 or 28-day
> inpatient studies (24/7).  There are frequent,
> daily interactions with myself, research technicians
> and nurses while in you live in the lab, however
> during your inpatient visits we remove all
> indications of clock time or time of day. 
> Therefore the following items are not permitted in
> the room: clocks, watches, cell phones, any devices
> with a clock (i.e., mp3 players or digital
> recorders), telephones, internet, and live radio or
> live TV.  Personal visitors are not permitted
> during the inpatient visits, but you may receive
> email, mail and newspapers (cd-version) through the
> investigator or study coordinator.  Unfortunately,
> due to the nature of the research guide dogs are not
> permitted in the rooms during inpatient visits,
> however we will pay the cost for your guide dogs
> care in your absence, if necessary.  The room is
> equipped with a laptop computer (JAWS) for personal
> use, a CD players, a VCR, Braille writer and 4-track
> players for your use during the study.
> To begin screening for this study you will need to
> fill-out our initial questionnaire. This
> questionnaire will help us determine whether you are
> eligible to screen for participation in this
> study.  If you are eligible to screen for this
> study, you will need to complete the following
> screening procedures, in the order indicated, before
> you are actually eligible to participate: #1. You
> will need to give us written consent to screen you
> for this study by signing a formal screening consent
> form; #2. You will need to fill out six screening
> forms and questionnaires; #3. You will need to have
> an interview with our psychologist over the phone;
> #4. You will need to schedule a physical with your
> doctor or one of ours in Boston if possible. If you
> are found eligible based on the results of your
> screening forms, physical exam and psychological
> evaluation, you will need to have a comprehensive
> eye exam with our neuro-ophthalmologist here in
> Boston.  In addition, you will need to review
> another research consent form with myself and
> another study representative, which we will be
> performed either in person or over the phone. 
> During this review session we will formally disclose
> the study procedures and what procedures we are
> asking you to perform during your participation. 
> If at this point you do not wish to participate you
> can withdraw your consent. However, you may withdraw
> your consent at any time during the study.  Signing
> either the screening consent form or the research
> consent form does not obligate you to screen,
> participate or complete this study.  Your signature
> only provides us with your written consent to start
> the screening and/or study procedures.  Your
> signature also indicates that we have informed you
> of all procedures, as well as the possible risks and
> benefits that accompany your participation.  You
> may ask questions at any time, and you may request
> counsel with one of our physicians regarding any
> medical or health concerns, issues or questions
> related to the study. Again, if you have any
> questions please feel free to contact me.  I have
> attached a copy of the initial questionnaire.  I,
> or my assistant, can also provide further details
> regarding procedures during inpatient visits as well
> as go over the initial questionnaire with you over
> the phone at a later date should you decide you
> would like to proceed.  Thank you for your time.
> Best regards,
> Joseph Hull
> Project Leader
> Division of Sleep Medicine
> Brigham and Women's Hospital
> 221 Longwood Avenue, BLI-438
> Boston, MA 02115Â  USA
> Phone: 1-888-828-4294
> Email: jhull at partners.org
> 
> 
> 
> THE FOLLOWING IS THE INITIAL QUESTIONNAIRE:
> Type your answers at the end of the question OR
> after the colon. You can mail or email this back to
> me.  Please be advised that e-mail is an unsecured
> median. If you do not wish to email sensitive
> information over e-mail please make arrangements to
> send via U.S. Post or your native postal carrier.
> 
> *Any personal and identifying information asked
> during this phone screen will need to be stored in
> the Division of Sleep Medicine Database. Do you give
> us permission to enter contact information in our
> Database? Yes or no?
> *If you are found ineligible, or are uninterested in
> this particular study, would you like to be informed
> about other studies in the future? Yes or no?
> 
> #1. Please give today's date:
> 
> #2. Please give your FIRST name ONLY:
> 
> #3. Please give your Email address:
> 
> #4. Please give your Phone number:
> 
> #5. Please give your Address:
> 
> #6. Please give your age and date of birth:
> 
> #7. How did you hear about the study?
> 
> #8. Have you ever done a research study before? If
> so, can you give details?
> 
> #9. Are you totally blind in both eyes?
> 
> #10. Do you have any conscious light perception in
> either eye?
> 
> #11. At what age and/or what year did you become
> totally blind in both eyes?
> 
> #12. What is the cause of your total blindness (if
> known)?
> 
> #13. Have one or both of your eyes been enucleated
> (removed)?
> 
> #14. Do you wear sunglasses, cosmetic scleral eye
> shells, or any type of protective eyewear?  Please
> explain?
> 
> #15. What is your height?
> 
> #16. What is your weight?
> 
> #17. Do you have any current medical illnesses or
> problems (if so please describe)? If female, are you
> currently pregnant?
> 
> #18. Do you have problems with your sleep (if so
> please describe)?
> 
> #19. Have you ever or do you currently use any
> sleeping pills?
> 
> #20. What is your usual wake time?
> 
> #21. Do you get up at a different time on some days?
> If so, when and why?
> 
> #22. What is your usual bedtime?
> 
> #23. Do you wake up in the night? If so how often,
> how long each time, why do you wake?
> 
> #24. Do you nap during the day? If so, how often do
> you nap, how long is your nap?
> 
> #25. Do you ever fall asleep without meaning to?
> 
> #26. Have you ever done night work or rotating shift
> work?
> 
> #27. If so, for each job how many days per week did
> you work nights, what were your work hours? For each
> job list what months and years you started and
> ended:
> 
> #28. Have you ever traveled to a different time
> zone? Where did you go? When did you come back?
> 
> The next set of questions will ask you about your
> past or current state of health. Please answer yes
> or no after the question mark. If you answer yes to
> any of the following medical issues below, please
> describe details, e.g., provide diagnosis, what
> treatment was given, is the condition ongoing?
> 
> #29. Have you had, or do you currently have heart or
> cardiovascular disease?
> 
> #30. Have you had, or do you currently have a heart
> murmur?
> 
> #31. Have you had, or do you currently have high
> blood pressure (also called hypertension)?
> 
> #32. Have you had, or do you currently have any
> endocrine disorders (such as thyroid disease)?
> 
> #33. Have you had, or do you currently have
> hepatitis?
> 
> #34. Have you ever received a hepatitis vaccination?
> 
> #35. Have you had, or do you currently have Asthma
> (what type of inhaler do you use)?
> 
> #36. Have you ever experienced Latex Sensitivity (if
> yes, what physical reaction did you experience?)?
> 
> #37. Have you had, or do you currently have Lung
> disease? (such as emphysema, chronic bronchitis,
> asthma)?
> 
> #38. Have you had, or do you currently have Kidney
> disease? (such as kidney failure, kidney infection,
> kidney stones)?
> 
> #39. Have you had, or do you currently have a
> Neurological disorder? (such as epilepsy, stroke,
> amnesia, migraine headaches, Parkinson's disease)?
> 
> #40. Have you ever suffered a head injury or loss of
> consciousness?
> 
> #41. Do you have Diabetes? (type 1 or type 2?)
> 
> #42. Have you had, or do you currently have a
> stomach or intestinal/digestive disorder? (such as
> ulcer, gastritis, gall bladder problems)?
> 
> #43. Do you have any hearing impairments?
> 
> #44. Have you ever received any psychiatric care or
> counseling?
> 
> #45. Have you ever been prescribed a medication from
> a psychiatrist?
> 
> #46. Do you have any family history of mental
> illness?
> 
> #47. Do you have any history of attempted suicide by
> yourself or a family member?
> 
> #48. Have you ever had any minor or major surgery?
> (What? When? Why?)
> 
> #49. Are you currently taking any of the following
> medications listed below? Please answer yes or no
> after the colon.
> Heart pill:
> Water pill (diuretic):
> Laxative:
> Sedatives (valium):
> Breathing pill:
> Sleeping pill:
> Health food supplement or herbal remedy (if so, what
> kind and what is it?):
> Pain pills, such as aspirin, Tylenol, Motrin (if so,
> why?):
> Circulation/blood pill:
> Antacid:
> Antihistamine:
> Birth control pill (female); if so what kind/brand:
> Acne medication:
> Any other pills, remedies or medications not
> mentioned? If so, what kind?:
> 
> #50. Do you currently or have you in the past used
> any of the following listed below? If yes, please
> describe details (when last used, how frequently)?
> 
> Marijuana:
> cocaine:
> amphetamines:
> Ecstasy:
> LSD, Mushrooms:
> Steroids (like D H E A, or Andro):
> cigarettes (if yes, how many per day?):
> Chewing tobacco:
> Cigars:
> Patches:
> 
> #51. How much coffee do you drink per day, per week,
> per month, or per year (whichever is the most
> common)?
> 
> #52. How much tea do you drink per day, per week,
> per month, or per year (whichever is the most
> common)?
> 
> #53. How many caffeinated soft drinks do you drink
> per day, per week, per month, or per year (whichever
> is the most common)?
> 
> #54. How much chocolate do you eat, or drink per
> day, per week, per month, or per year (whichever is
> the most common)?
> 
> #55. How many alcoholic drinks do you drink (please
> specify type, such as beer, wine, liquor, etc.) per
> day, per week, per month, or per year (whichever is
> the most common)?
> 
> You have now completed the initial questionnaire;
> thank you for your time.
> 
> 
> Study Description
> The following is the study description for a
> three-part study.
> Part 1: A 6-day study while you live in our
> laboratory
> Part 2: An 8 to16 week study while you live at home
> Part 3: A 15 or 28-day study while you live in
> laboratory
> Study Coordinator: Joseph Hull
> jhull at partners.org
> 
> We are currently seeking healthy, totally blind men
> and women ages 18-70 to participate in a home and
> laboratory research study.  The study consists of
> two laboratory visits that are separated by an eight
> to sixteen week home-based field study.  The
> purpose of this study is to increase knowledge about
> the human biological clock.  The knowledge gained
> from this study may improve the health, productivity
> and safety of not only totally blind individuals,
> but also those with a high prevalence of insomnia,
> such as shift workers and the elderly.
> 
> Prior to entering the study we will ask you to
> complete a screening process, which involves filling
> out screening forms, having a physical exam with a
> physician, blood and urine tests, having an
> ophthalmological eye exam and completing an
> assessment with our staff  psychologist.  The
> screening can be completed in up to three to five
> visits.
> 
> In order for the study to achieve the highest
> quality results you will be asked to participate in
> both a home-based outpatient protocol and two
> inpatient protocols, which will require two visits
> to the hospital.  You will first remain in the
> hospital for your inpatient visit #1 for the
> duration of 6 days.  Upon completing the initial 6
> days, you will return home for an 8 to 16-week
> home-based outpatient protocol.  The length of your
> home-based protocol will be determined in the first
> few weeks after starting home-based protocol. Upon
> completing the home-based protocol, you will return
> to the hospital for your inpatient visit #2.  Your
> inpatient visit #2 will be either 15 or 28 days in
> duration.  The length of your inpatient visit #2
> will be determined by the results obtained during
> inpatient visit #1.  During each inpatient visit,
> we will request that you not leave your suite until
> the completion of the inpatient protocol.  This is
> unless you choose to withdraw from the study, which
> is your option at any point (see payment section
> below).
> 
> Inpatient Study Conditions
> Environment free of time cues:Â  The study seeks to
> create an environment free of time cues.  Anything
> that might give study participants a time cue is
> prohibited.  This means that there are no windows
> in your suite as well as no watches, clocks, live
> TV’s, radios, phone calls or visitors, although
> you will have frequent interaction with the research
> staff and you are able to listen to tapes and
> CD’s.
> 
> Constant Routines: For 3 to 5 times during the study
> you will be asked to participate in a procedure
> called a constant routine. This procedure will
> require you to remain in bed, awake, and relatively
> inactive for up to 20-70 hours. You will be given
> the opportunity to sleep between these periods of
> extended wakefulness. We will monitor your brain
> waves continuously during these constant routines,
> and proportioned snacks will be provided
> periodically, such that your overall daily caloric
> intake will equal the amount you would receive in
> three meals and a snack.
> 
> Constant Posture: On as many as 2 occasions during a
> visit#2 inpatient protocols you will be asked to
> participate in a procedure called a constant posture
> protocol. This procedure will require you to remain
> relatively inactive while in bed and for up to 40
> hours, but you will be given an opportunity to sleep
> during this time.. We will monitor your brain waves
> continuously during these constant postures, and
> three meals and a snack will be provided before and
> after the sleep opportunity.
> 
> Cognitive Performance Battery: During the study you
> will frequently take a variety of auditory
> performance tests. The tests are presented on a
> computer. You respond to these tests by using the
> keys on a computer keyboard or a two-button response
> pad. The performance tests are of several types and
> test for reaction time, memory, simple math skills
> and your current mood and alertness.
> 
> 
> Free Time:Â  During the study you will have
> significant amounts of free time during which you
> may read, write, listen to music and even play
> musical instruments. However, no exercise other than
> light stretching will be permitted because it
> releases stress hormones into your blood stream and
> elevates body temperature, and this could affect the
> results of our data.
> 
> What We Monitor
> 
> For approximately two weeks prior to entering the
> study for inpatient visit #1 until the completion of
> the study, your sleeping pattern will be
> monitored.  You will wear a wrist activity recorder
> (called an Actiwatch), which measures your activity
> and movement during the day and night. While wearing
> the watch you will be asked to come to the
> recruiting office to have your activity information
> downloaded into our files.  If you live outside the
> Boston area, arrangements will be made for you to
> send back and receive Actiwatches at no cost to you.
> You will also need to keep a logbook at home
> regarding your sleep/wake schedule every morning and
> night.
> 
> 
> During the study the following will be performed:
> Â -Electroencephalogram (EEG): Every night and day
> during scheduled sleep and wakefulness your
> brainwaves will be recorded with an EEG.  Just
> before you go to sleep, you will be asked to wash
> your face with special soap and cleanse the skin
> with an alcohol swab.  Small electrodes will be
> placed on the skin of your scalp, face and chin. 
> These are held in place with special glue that can
> be removed with shampoo.  It is not invasive and
> you do not need to cut or shave your hair for the
> study.  After your scheduled waketimes on non-CR
> days you will have the opportunity shower where
> after you will have electrodes reapplied in a
> similar fashion.
> 
> -Temperature:Â  Your body temperature is monitored
> throughout the study.  This is done using a small
> rectal temperature sensor. This sensor is a very
> thin flexible piece of wire coated in plastic, which
> you would insert and remove yourself. You will be
> asked to remove it for showers and bowel
> movements.  There is tape that marks off the max
> insertion length (~10cm); technicians will
> periodically ask you to check that the sensor is
> inserted up to the tape (alcohol wipes will be
> available).
> 
> -Blood Drawings:Â  During both inpatient visits you
> will have an IV catheter inserted into your
> forearm.  It will remain in your arm for blood
> drawings at various times during both sleep and wake
> periods. The total amount of blood that will be
> taken over the course of the study, including blood
> samples drawn during your screening physical exam
> and inpatient visit’s #1 and # 2 will be
> approximately 32 ounces (approximately 2 pints). A
> very small amount of heparin (an anti-coagulant)
> will run through the IV to prevent clotting in the
> tube.
> 
> -Saliva Samples: During several segments of the
> study we will ask you to emit a small amount of
> saliva from your mouth into a test tube so that we
> can collect salivary hormone
> samples.          
> 
> -Urine Samples: Throughout the entire study urine
> will be collected at frequent times. This allows us
> to monitor specific hormones in your systems. 
> Technicians will ask you periodically to empty your
> bladder; we ask that you try even if you feel that
> you do not have to go.
> 
> Restrictions:Â  The following substances are
> prohibited for the duration of the study, starting
> at the beginning of the screening process until
> completion of the study:
> v     Alcohol
> v     Caffeine Products (coffee, tea,
> soft-drinks, chocolate)
> v     Nicotine
> v     Prescription or non-prescription (over the
> counter) drugs i.e. patches, vitamins, or steroidal
> creams
> v     Poppy seeds
> v     Recreational or Street Drugs
> v     Other foreign substances
> v     Food other that that provided by our
> dietary staff (while in the actual study)
> Â *If in doubt about a particular substance, please
> ask before taking it.
> 
> Payment for participation:
> Physical exam:Â  $25 one time
> Eye exam:Â  $25 one time
> Diaries:Â  $25/week
> Wearing Actiwatch:Â  $25/week
> 48 h Urine collection (Home-based):Â  $25/ 24-hour
> collection at home
> Returning all actiwatches:Â  $25 last return
> In-study at the hospital:Â  $150/day
> Completion bonus:Â  $250/week inpatient stay
> (pro-rated)
> Total = up to $9,300.00
> 
> Payment is in the form of one check 4 weeks after
> completion of the study.
> 
> If the entire study is not completed for any reason,
> subjects are paid for their participation up through
> their last day, but none of the $250/week completion
> bonus is paid.  Also, there is no monetary
> compensation paid to any subject whose blood and/ or
> urine tests indicate use of drugs, alcohol,
> caffeine, nicotine, non-approved prescription or
> over the counter drugs, recreation/street drugs,
> illicit drugs or any other foreign substances.
> 
> Other Benefits
> Although there may be no direct benefit to you from
> participating in this study, we will make known to
> you, upon conclusion and analysis of the data, the
> information gathered from the testing.  There is
> also the chance that the pre-study screening or
> various blood and urine samples taken during the
> study will reveal some medical abnormality.  This
> information will be conveyed to you at once,
> together with a recommendation to a local clinic or
> physician.
> 
> Â 
> 
> Â 
> 
> Â 
> 
> Tess Cooper
> 
> Research Assistant
> 
> Division of Sleep Medicine
> 
> Brigham and Women's Hospital
> 
> 221 Longwood Avenue
> 
> Room #425
> 
> Boston, MA 02115
> 
> phone (617) 525-8412
> 
> fax (617) 582-6006
> 
> tcooper at rics.bwh.harvard.edu
> 
> Â 
> 
> Â 
> 
> Â 
> 
> 
> The information transmitted in this electronic
> communication is intended only for the person or
> entity to whom it is addressed and may contain
> confidential and/or privileged material. Any review,
> retransmission, dissemination or other use of or
> taking of any action in reliance upon this
> information by persons or entities other than the
> intended recipient is prohibited. If you received
> this information in error, please contact the
> Compliance HelpLine at 800-856-1983 and properly
> dispose of this information.
> 
> 
> Email and AIM finally together. You've gotta check
> out free AOL Mail!
> 
> 
> 
> 
> 
> 
> 
> -----Original Message-----
> From: atthetopoflife at aol.com
> To: CelebritySpotlight at sbcglobal.n;
> monicacalhoun1 at aol.com
> Sent: Sun, 11 Nov 2007 6:41 pm
> Subject: Fwd: Harvard Sleep Study! From: Lorine W.
> Calhoun, from chr. (323) 299-8620
> 
> 
> 
> 
> 
> -----Original Message-----
> From: atthetopoflife at aol.com
> To: sherrynmarie at Yahoo.com
> Sent: Sun, 11 Nov 2007 6:20 pm
> Subject: Fwd: Harvard Sleep Study! From: Lorine W.
> Calhoun, from chr. (323) 299-8620
> 
> 
> 
> 
> 
> 
> Hello Lorine,
> Thank you for your inquiry.  This email is pretty
> long, but it contains a lot of information (below)
> regarding the research study. Please read it over
> carefully and let me know if you have any
> questions.  The first section provides general
> information regarding the study from the study
> project leader Joseph Hull. Below the general
> information is a questionnaire and then below the
> questionnaire is a study description with more
> details about the inpatient portion of the study.
> Thank you again for your interest in our Sleep
> Research Study.
> 
> Best regards,
> 
> Tess Cooper
> 
> Research Assistant IÂ Â Â Â Â Â Â Â Â Â 
> Â Â Â Â Â Â Â Â Â Â Â Â Â Â  
> Division of Sleep Medicine
> Brigham and Women's Hospital
> 221 Longwood Avenue, BLI-425
> Boston, MA 02115Â  USA
> Phone: 1-1888-828-4294
> Email: tcooper at rics.bwh.harvard.edu
> 
> 
> GENERAL INFORMATION REGARDING PROTOCOL TITLED,
> "PHOTIC AND NONPHOTIC INPUT TO THE HUMAN CIRCADIAN
> SYSTEM:"
> 
> Â Â Â Â Â Â Â  Thank you for your inquiry about the
> research study that we are conducting here in
> Boston.  First, I should introduce myself. My name
> is, Joseph Hull. I am a co-investigator of the study
> working with Dr. Charles A. Czeisler, Ph.D., M.D.
> and Dr. Steven W. Lockley, Ph.D. at the Division of
> Sleep Medicine, Harvard Medical School, Brigham and
> Women's Hospital in Boston, MA.  We are currently
> conducting research to better understand the nature
> of human sleep and circadian rhythms (i.e., the
> human body clock) in blind individuals with no
> conscious light perception, as well as understanding
> how the loss of light perception affects the human
> body clock. This research will also increase our
> knowledge on how the loss of light perception
> affects the human body clock in daily life. We are
> looking for healthy participants who have no light
> perception, do not have any current medical problems
> or take any prescription medications.  The duration
> of this study is approximately 3-5 consecutive
> months   Individuals who are interested and are
> willing to participate must first go through health
> screening to determine your eligibility. During the
> duration of the screening process, we will ask you
> to record daily sleep diaries, collect urine samples
> for a 48 h period each week, and wear a wrist-watch
> that monitors and records the surrounding light
> levels and your motor activity.  If your screening
> results that you are healthy and meet our study
> criteria, and you provide written consent to
> participate, you will then be eligible to
> participate in the study. You will be asked to
> participate in a three-part study.  During part 1
> of the study, we ask you to live in our lab for 6
> days.  As a research subject you will be asked to
> refrain from any drug use, including alcohol,
> caffeine, nicotine, over-the-counter medications,
> narcotics, etc. After completing part 1 of the study
> you will return home for part 2 of the study. During
> part 2 of the study, we will again ask you to keep
> daily sleep diaries, collect urine samples and wear
> a wrist-watch that records light levels and your
> motor activity for up to eight to sixteen weeks. 
> Throughout your home-based study we may also ask you
> to keep a regular 8-hour time in bed schedule. After
> completing part 2 of the study, you will then be
> asked to live again at our laboratory for either 15
> or 28 days.  The duration of your second visit will
> be decided by the results obtained during part 1 of
> the study.  We will arrange and pay for your
> transportation, including flights to and from Boston
> and any other costs associated with your
> participation.  We will try to accommodate the
> start dates to fit into your schedule as best as
> possible, however we may need to schedule your
> second inpatient visit on particular date.  You
> will be compensated for your time spent in the
> laboratory and also for completing particular study
> procedures.  Depending on the total duration of
> your individual study, you could receive up to
> $9,300.00 for your participation.
> During your inpatient visit, you will in our sleep
> laboratory at the Brigham and Women's Hospital in
> Boston.  You will live continuously in your own
> room for the duration of the 6 and 15 or 28-day
> inpatient studies (24/7).  There are frequent,
> daily interactions with myself, research technicians
> and nurses while in you live in the lab, however
> during your inpatient visits we remove all
> indications of clock time or time of day. 
> Therefore the following items are not permitted in
> the room: clocks, watches, cell phones, any devices
> with a clock (i.e., mp3 players or digital
> recorders), telephones, internet, and live radio or
> live TV.  Personal visitors are not permitted
> during the inpatient visits, but you may receive
> email, mail and newspapers (cd-version) through the
> investigator or study coordinator.  Unfortunately,
> due to the nature of the research guide dogs are not
> permitted in the rooms during inpatient visits,
> however we will pay the cost for your guide dogs
> care in your absence, if necessary.  The room is
> equipped with a laptop computer (JAWS) for personal
> use, a CD players, a VCR, Braille writer and 4-track
> players for your use during the study.
> To begin screening for this study you will need to
> fill-out our initial questionnaire. This
> questionnaire will help us determine whether you are
> eligible to screen for participation in this
> study.  If you are eligible to screen for this
> study, you will need to complete the following
> screening procedures, in the order indicated, before
> you are actually eligible to participate: #1. You
> will need to give us written consent to screen you
> for this study by signing a formal screening consent
> form; #2. You will need to fill out six screening
> forms and questionnaires; #3. You will need to have
> an interview with our psychologist over the phone;
> #4. You will need to schedule a physical with your
> doctor or one of ours in Boston if possible. If you
> are found eligible based on the results of your
> screening forms, physical exam and psychological
> evaluation, you will need to have a comprehensive
> eye exam with our neuro-ophthalmologist here in
> Boston.  In addition, you will need to review
> another research consent form with myself and
> another study representative, which we will be
> performed either in person or over the phone. 
> During this review session we will formally disclose
> the study procedures and what procedures we are
> asking you to perform during your participation. 
> If at this point you do not wish to participate you
> can withdraw your consent. However, you may withdraw
> your consent at any time during the study.  Signing
> either the screening consent form or the research
> consent form does not obligate you to screen,
> participate or complete this study.  Your signature
> only provides us with your written consent to start
> the screening and/or study procedures.  Your
> signature also indicates that we have informed you
> of all procedures, as well as the possible risks and
> benefits that accompany your participation.  You
> may ask questions at any time, and you may request
> counsel with one of our physicians regarding any
> medical or health concerns, issues or questions
> related to the study. Again, if you have any
> questions please feel free to contact me.  I have
> attached a copy of the initial questionnaire.  I,
> or my assistant, can also provide further details
> regarding procedures during inpatient visits as well
> as go over the initial questionnaire with you over
> the phone at a later date should you decide you
> would like to proceed.  Thank you for your time.
> Best regards,
> Joseph Hull
> Project Leader
> Division of Sleep Medicine
> Brigham and Women's Hospital
> 221 Longwood Avenue, BLI-438
> Boston, MA 02115Â  USA
> Phone: 1-888-828-4294
> Email: jhull at partners.org
> 
> 
> 
> THE FOLLOWING IS THE INITIAL QUESTIONNAIRE:
> Type your answers at the end of the question OR
> after the colon. You can mail or email this back to
> me.  Please be advised that e-mail is an unsecured
> median. If you do not wish to email sensitive
> information over e-mail please make arrangements to
> send via U.S. Post or your native postal carrier.
> 
> *Any personal and identifying information asked
> during this phone screen will need to be stored in
> the Division of Sleep Medicine Database. Do you give
> us permission to enter contact information in our
> Database? Yes or no?
> *If you are found ineligible, or are uninterested in
> this particular study, would you like to be informed
> about other studies in the future? Yes or no?
> 
> #1. Please give today's date:
> 
> #2. Please give your FIRST name ONLY:
> 
> #3. Please give your Email address:
> 
> #4. Please give your Phone number:
> 
> #5. Please give your Address:
> 
> #6. Please give your age and date of birth:
> 
> #7. How did you hear about the study?
> 
> #8. Have you ever done a research study before? If
> so, can you give details?
> 
> #9. Are you totally blind in both eyes?
> 
> #10. Do you have any conscious light perception in
> either eye?
> 
> #11. At what age and/or what year did you become
> totally blind in both eyes?
> 
> #12. What is the cause of your total blindness (if
> known)?
> 
> #13. Have one or both of your eyes been enucleated
> (removed)?
> 
> #14. Do you wear sunglasses, cosmetic scleral eye
> shells, or any type of protective eyewear?  Please
> explain?
> 
> #15. What is your height?
> 
> #16. What is your weight?
> 
> #17. Do you have any current medical illnesses or
> problems (if so please describe)? If female, are you
> currently pregnant?
> 
> #18. Do you have problems with your sleep (if so
> please describe)?
> 
> #19. Have you ever or do you currently use any
> sleeping pills?
> 
> #20. What is your usual wake time?
> 
> #21. Do you get up at a different time on some days?
> If so, when and why?
> 
> #22. What is your usual bedtime?
> 
> #23. Do you wake up in the night? If so how often,
> how long each time, why do you wake?
> 
> #24. Do you nap during the day? If so, how often do
> you nap, how long is your nap?
> 
> #25. Do you ever fall asleep without meaning to?
> 
> #26. Have you ever done night work or rotating shift
> work?
> 
> #27. If so, for each job how many days per week did
> you work nights, what were your work hours? For each
> job list what months and years you started and
> ended:
> 
> #28. Have you ever traveled to a different time
> zone? Where did you go? When did you come back?
> 
> The next set of questions will ask you about your
> past or current state of health. Please answer yes
> or no after the question mark. If you answer yes to
> any of the following medical issues below, please
> describe details, e.g., provide diagnosis, what
> treatment was given, is the condition ongoing?
> 
> #29. Have you had, or do you currently have heart or
> cardiovascular disease?
> 
> #30. Have you had, or do you currently have a heart
> murmur?
> 
> #31. Have you had, or do you currently have high
> blood pressure (also called hypertension)?
> 
> #32. Have you had, or do you currently have any
> endocrine disorders (such as thyroid disease)?
> 
> #33. Have you had, or do you currently have
> hepatitis?
> 
> #34. Have you ever received a hepatitis vaccination?
> 
> #35. Have you had, or do you currently have Asthma
> (what type of inhaler do you use)?
> 
> #36. Have you ever experienced Latex Sensitivity (if
> yes, what physical reaction did you experience?)?
> 
> #37. Have you had, or do you currently have Lung
> disease? (such as emphysema, chronic bronchitis,
> asthma)?
> 
> #38. Have you had, or do you currently have Kidney
> disease? (such as kidney failure, kidney infection,
> kidney stones)?
> 
> #39. Have you had, or do you currently have a
> Neurological disorder? (such as epilepsy, stroke,
> amnesia, migraine headaches, Parkinson's disease)?
> 
> #40. Have you ever suffered a head injury or loss of
> consciousness?
> 
> #41. Do you have Diabetes? (type 1 or type 2?)
> 
> #42. Have you had, or do you currently have a
> stomach or intestinal/digestive disorder? (such as
> ulcer, gastritis, gall bladder problems)?
> 
> #43. Do you have any hearing impairments?
> 
> #44. Have you ever received any psychiatric care or
> counseling?
> 
> #45. Have you ever been prescribed a medication from
> a psychiatrist?
> 
> #46. Do you have any family history of mental
> illness?
> 
> #47. Do you have any history of attempted suicide by
> yourself or a family member?
> 
> #48. Have you ever had any minor or major surgery?
> (What? When? Why?)
> 
> #49. Are you currently taking any of the following
> medications listed below? Please answer yes or no
> after the colon.
> Heart pill:
> Water pill (diuretic):
> Laxative:
> Sedatives (valium):
> Breathing pill:
> Sleeping pill:
> Health food supplement or herbal remedy (if so, what
> kind and what is it?):
> Pain pills, such as aspirin, Tylenol, Motrin (if so,
> why?):
> Circulation/blood pill:
> Antacid:
> Antihistamine:
> Birth control pill (female); if so what kind/brand:
> Acne medication:
> Any other pills, remedies or medications not
> mentioned? If so, what kind?:
> 
> #50. Do you currently or have you in the past used
> any of the following listed below? If yes, please
> describe details (when last used, how frequently)?
> 
> Marijuana:
> cocaine:
> amphetamines:
> Ecstasy:
> LSD, Mushrooms:
> Steroids (like D H E A, or Andro):
> cigarettes (if yes, how many per day?):
> Chewing tobacco:
> Cigars:
> Patches:
> 
> #51. How much coffee do you drink per day, per week,
> per month, or per year (whichever is the most
> common)?
> 
> #52. How much tea do you drink per day, per week,
> per month, or per year (whichever is the most
> common)?
> 
> #53. How many caffeinated soft drinks do you drink
> per day, per week, per month, or per year (whichever
> is the most common)?
> 
> #54. How much chocolate do you eat, or drink per
> day, per week, per month, or per year (whichever is
> the most common)?
> 
> #55. How many alcoholic drinks do you drink (please
> specify type, such as beer, wine, liquor, etc.) per
> day, per week, per month, or per year (whichever is
> the most common)?
> 
> You have now completed the initial questionnaire;
> thank you for your time.
> 
> 
> Study Description
> The following is the study description for a
> three-part study.
> Part 1: A 6-day study while you live in our
> laboratory
> Part 2: An 8 to16 week study while you live at home
> Part 3: A 15 or 28-day study while you live in
> laboratory
> Study Coordinator: Joseph Hull
> jhull at partners.org
> 
> We are currently seeking healthy, totally blind men
> and women ages 18-70 to participate in a home and
> laboratory research study.  The study consists of
> two laboratory visits that are separated by an eight
> to sixteen week home-based field study.  The
> purpose of this study is to increase knowledge about
> the human biological clock.  The knowledge gained
> from this study may improve the health, productivity
> and safety of not only totally blind individuals,
> but also those with a high prevalence of insomnia,
> such as shift workers and the elderly.
> 
> Prior to entering the study we will ask you to
> complete a screening process, which involves filling
> out screening forms, having a physical exam with a
> physician, blood and urine tests, having an
> ophthalmological eye exam and completing an
> assessment with our staff  psychologist.  The
> screening can be completed in up to three to five
> visits.
> 
> In order for the study to achieve the highest
> quality results you will be asked to participate in
> both a home-based outpatient protocol and two
> inpatient protocols, which will require two visits
> to the hospital.  You will first remain in the
> hospital for your inpatient visit #1 for the
> duration of 6 days.  Upon completing the initial 6
> days, you will return home for an 8 to 16-week
> home-based outpatient protocol.  The length of your
> home-based protocol will be determined in the first
> few weeks after starting home-based protocol. Upon
> completing the home-based protocol, you will return
> to the hospital for your inpatient visit #2.  Your
> inpatient visit #2 will be either 15 or 28 days in
> duration.  The length of your inpatient visit #2
> will be determined by the results obtained during
> inpatient visit #1.  During each inpatient visit,
> we will request that you not leave your suite until
> the completion of the inpatient protocol.  This is
> unless you choose to withdraw from the study, which
> is your option at any point (see payment section
> below).
> 
> Inpatient Study Conditions
> Environment free of time cues:Â  The study seeks to
> create an environment free of time cues.  Anything
> that might give study participants a time cue is
> prohibited.  This means that there are no windows
> in your suite as well as no watches, clocks, live
> TV’s, radios, phone calls or visitors, although
> you will have frequent interaction with the research
> staff and you are able to listen to tapes and
> CD’s.
> 
> Constant Routines: For 3 to 5 times during the study
> you will be asked to participate in a procedure
> called a constant routine. This procedure will
> require you to remain in bed, awake, and relatively
> inactive for up to 20-70 hours. You will be given
> the opportunity to sleep between these periods of
> extended wakefulness. We will monitor your brain
> waves continuously during these constant routines,
> and proportioned snacks will be provided
> periodically, such that your overall daily caloric
> intake will equal the amount you would receive in
> three meals and a snack.
> 
> Constant Posture: On as many as 2 occasions during a
> visit#2 inpatient protocols you will be asked to
> participate in a procedure called a constant posture
> protocol. This procedure will require you to remain
> relatively inactive while in bed and for up to 40
> hours, but you will be given an opportunity to sleep
> during this time.. We will monitor your brain waves
> continuously during these constant postures, and
> three meals and a snack will be provided before and
> after the sleep opportunity.
> 
> Cognitive Performance Battery: During the study you
> will frequently take a variety of auditory
> performance tests. The tests are presented on a
> computer. You respond to these tests by using the
> keys on a computer keyboard or a two-button response
> pad. The performance tests are of several types and
> test for reaction time, memory, simple math skills
> and your current mood and alertness.
> 
> 
> Free Time:Â  During the study you will have
> significant amounts of free time during which you
> may read, write, listen to music and even play
> musical instruments. However, no exercise other than
> light stretching will be permitted because it
> releases stress hormones into your blood stream and
> elevates body temperature, and this could affect the
> results of our data.
> 
> What We Monitor
> 
> For approximately two weeks prior to entering the
> study for inpatient visit #1 until the completion of
> the study, your sleeping pattern will be
> monitored.  You will wear a wrist activity recorder
> (called an Actiwatch), which measures your activity
> and movement during the day and night. While wearing
> the watch you will be asked to come to the
> recruiting office to have your activity information
> downloaded into our files.  If you live outside the
> Boston area, arrangements will be made for you to
> send back and receive Actiwatches at no cost to you.
> You will also need to keep a logbook at home
> regarding your sleep/wake schedule every morning and
> night.
> 
> 
> During the study the following will be performed:
> Â -Electroencephalogram (EEG): Every night and day
> during scheduled sleep and wakefulness your
> brainwaves will be recorded with an EEG.  Just
> before you go to sleep, you will be asked to wash
> your face with special soap and cleanse the skin
> with an alcohol swab.  Small electrodes will be
> placed on the skin of your scalp, face and chin. 
> These are held in place with special glue that can
> be removed with shampoo.  It is not invasive and
> you do not need to cut or shave your hair for the
> study.  After your scheduled waketimes on non-CR
> days you will have the opportunity shower where
> after you will have electrodes reapplied in a
> similar fashion.
> 
> -Temperature:Â  Your body temperature is monitored
> throughout the study.  This is done using a small
> rectal temperature sensor. This sensor is a very
> thin flexible piece of wire coated in plastic, which
> you would insert and remove yourself. You will be
> asked to remove it for showers and bowel
> movements.  There is tape that marks off the max
> insertion length (~10cm); technicians will
> periodically ask you to check that the sensor is
> inserted up to the tape (alcohol wipes will be
> available).
> 
> -Blood Drawings:Â  During both inpatient visits you
> will have an IV catheter inserted into your
> forearm.  It will remain in your arm for blood
> drawings at various times during both sleep and wake
> periods. The total amount of blood that will be
> taken over the course of the study, including blood
> samples drawn during your screening physical exam
> and inpatient visit’s #1 and # 2 will be
> approximately 32 ounces (approximately 2 pints). A
> very small amount of heparin (an anti-coagulant)
> will run through the IV to prevent clotting in the
> tube.
> 
> -Saliva Samples: During several segments of the
> study we will ask you to emit a small amount of
> saliva from your mouth into a test tube so that we
> can collect salivary hormone
> samples.          
> 
> -Urine Samples: Throughout the entire study urine
> will be collected at frequent times. This allows us
> to monitor specific hormones in your systems. 
> Technicians will ask you periodically to empty your
> bladder; we ask that you try even if you feel that
> you do not have to go.
> 
> Restrictions:Â  The following substances are
> prohibited for the duration of the study, starting
> at the beginning of the screening process until
> completion of the study:
> v     Alcohol
> v     Caffeine Products (coffee, tea,
> soft-drinks, chocolate)
> v     Nicotine
> v     Prescription or non-prescription (over the
> counter) drugs i.e. patches, vitamins, or steroidal
> creams
> v     Poppy seeds
> v     Recreational or Street Drugs
> v     Other foreign substances
> v     Food other that that provided by our
> dietary staff (while in the actual study)
> Â *If in doubt about a particular substance, please
> ask before taking it.
> 
> Payment for participation:
> Physical exam:Â  $25 one time
> Eye exam:Â  $25 one time
> Diaries:Â  $25/week
> Wearing Actiwatch:Â  $25/week
> 48 h Urine collection (Home-based):Â  $25/ 24-hour
> collection at home
> Returning all actiwatches:Â  $25 last return
> In-study at the hospital:Â  $150/day
> Completion bonus:Â  $250/week inpatient stay
> (pro-rated)
> Total = up to $9,300.00
> 
> Payment is in the form of one check 4 weeks after
> completion of the study.
> 
> If the entire study is not completed for any reason,
> subjects are paid for their participation up through
> their last day, but none of the $250/week completion
> bonus is paid.  Also, there is no monetary
> compensation paid to any subject whose blood and/ or
> urine tests indicate use of drugs, alcohol,
> caffeine, nicotine, non-approved prescription or
> over the counter drugs, recreation/street drugs,
> illicit drugs or any other foreign substances.
> 
> Other Benefits
> Although there may be no direct benefit to you from
> participating in this study, we will make known to
> you, upon conclusion and analysis of the data, the
> information gathered from the testing.  There is
> also the chance that the pre-study screening or
> various blood and urine samples taken during the
> study will reveal some medical abnormality.  This
> information will be conveyed to you at once,
> together with a recommendation to a local clinic or
> physician.
> 
> Â 
> 
> Â 
> 
> Â 
> 
> Tess Cooper
> 
> Research Assistant
> 
> Division of Sleep Medicine
> 
> Brigham and Women's Hospital
> 
> 221 Longwood Avenue
> 
> Room #425
> 
> Boston, MA 02115
> 
> phone (617) 525-8412
> 
> fax (617) 582-6006
> 
> tcooper at rics.bwh.harvard.edu
> 
> Â 
> 
> Â 
> 
> Â 
> 
> 
> The information transmitted in this electronic
> communication is intended only for the person or
> entity to whom it is addressed and may contain
> confidential and/or privileged material. Any review,
> retransmission, dissemination or other use of or
> taking of any action in reliance upon this
> information by persons or entities other than the
> intended recipient is prohibited. If you received
> this information in error, please contact the
> Compliance HelpLine at 800-856-1983 and properly
> dispose of this information.
> 
> 
> 
> 
> -----Original Message-----
> From: Tess Cooper <tcooper at rics.bwh.harvard.edu>
> To: atthetopoflife at aol.com
> Sent: Thu, 8 Nov 2007 8:00 am
> Subject: Harvard Sleep Study!
> 
> 
> 
> 
> Hello Lorine,
> Thank you for your inquiry.  This email is pretty
> long, but it contains a lot of information (below)
> regarding the research study. Please read it over
> carefully and let me know if you have any
> questions.  The first section provides general
> information regarding the study from the study
> project leader Joseph Hull. Below the general
> information is a questionnaire and then below the
> questionnaire is a study description with more
> details about the inpatient portion of the study.
> Thank you again for your interest in our Sleep
> Research Study.
> 
> Best regards,
> 
> Tess Cooper
> 
> Research Assistant IÂ Â Â Â Â Â Â Â Â Â 
> Â Â Â Â Â Â Â Â Â Â Â Â Â Â  
> Division of Sleep Medicine
> Brigham and Women's Hospital
> 221 Longwood Avenue, BLI-425
> Boston, MA 02115Â  USA
> Phone: 1-1888-828-4294
> Email: tcooper at rics.bwh.harvard.edu
> 
> 
> GENERAL INFORMATION REGARDING PROTOCOL TITLED,
> "PHOTIC AND NONPHOTIC INPUT TO THE HUMAN CIRCADIAN
> SYSTEM:"
> 
> Â Â Â Â Â Â Â  Thank you for your inquiry about the
> research study that we are conducting here in
> Boston.  First, I should introduce myself. My name
> is, Joseph Hull. I am a co-investigator of the study
> working with Dr. Charles A. Czeisler, Ph.D., M.D.
> and Dr. Steven W. Lockley, Ph.D. at the Division of
> Sleep Medicine, Harvard Medical School, Brigham and
> Women's Hospital in Boston, MA.  We are currently
> conducting research to better understand the nature
> of human sleep and circadian rhythms (i.e., the
> human body clock) in blind individuals with no
> conscious light perception, as well as understanding
> how the loss of light perception affects the human
> body clock. This research will also increase our
> knowledge on how the loss of light perception
> affects the human body clock in daily life. We are
> looking for healthy participants who have no light
> perception, do not have any current medical problems
> or take any prescription medications.  The duration
> of this study is approximately 3-5 consecutive
> months   Individuals who are interested and are
> willing to participate must first go through health
> screening to determine your eligibility. During the
> duration of the screening process, we will ask you
> to record daily sleep diaries, collect urine samples
> for a 48 h period each week, and wear a wrist-watch
> that monitors and records the surrounding light
> levels and your motor activity.  If your screening
> results that you are healthy and meet our study
> criteria, and you provide written consent to
> participate, you will then be eligible to
> participate in the study. You will be asked to
> participate in a three-part study.  During part 1
> of the study, we ask you to live in our lab for 6
> days.  As a research subject you will be asked to
> refrain from any drug use, including alcohol,
> caffeine, nicotine, over-the-counter medications,
> narcotics, etc. After completing part 1 of the study
> you will return home for part 2 of the study. During
> part 2 of the study, we will again ask you to keep
> daily sleep diaries, collect urine samples and wear
> a wrist-watch that records light levels and your
> motor activity for up to eight to sixteen weeks. 
> Throughout your home-based study we may also ask you
> to keep a regular 8-hour time in bed schedule. After
> completing part 2 of the study, you will then be
> asked to live again at our laboratory for either 15
> or 28 days.  The duration of your second visit will
> be decided by the results obtained during part 1 of
> the study.  We will arrange and pay for your
> transportation, including flights to and from Boston
> and any other costs associated with your
> participation.  We will try to accommodate the
> start dates to fit into your schedule as best as
> possible, however we may need to schedule your
> second inpatient visit on particular date.  You
> will be compensated for your time spent in the
> laboratory and also for completing particular study
> procedures.  Depending on the total duration of
> your individual study, you could receive up to
> $9,300.00 for your participation.
> During your inpatient visit, you will in our sleep
> laboratory at the Brigham and Women's Hospital in
> Boston.  You will live continuously in your own
> room for the duration of the 6 and 15 or 28-day
> inpatient studies (24/7).  There are frequent,
> daily interactions with myself, research technicians
> and nurses while in you live in the lab, however
> during your inpatient visits we remove all
> indications of clock time or time of day. 
> Therefore the following items are not permitted in
> the room: clocks, watches, cell phones, any devices
> with a clock (i.e., mp3 players or digital
> recorders), telephones, internet, and live radio or
> live TV.  Personal visitors are not permitted
> during the inpatient visits, but you may receive
> email, mail and newspapers (cd-version) through the
> investigator or study coordinator.  Unfortunately,
> due to the nature of the research guide dogs are not
> permitted in the rooms during inpatient visits,
> however we will pay the cost for your guide dogs
> care in your absence, if necessary.  The room is
> equipped with a laptop computer (JAWS) for personal
> use, a CD players, a VCR, Braille writer and 4-track
> players for your use during the study.
> To begin screening for this study you will need to
> fill-out our initial questionnaire. This
> questionnaire will help us determine whether you are
> eligible to screen for participation in this
> study.  If you are eligible to screen for this
> study, you will need to complete the following
> screening procedures, in the order indicated, before
> you are actually eligible to participate: #1. You
> will need to give us written consent to screen you
> for this study by signing a formal screening consent
> form; #2. You will need to fill out six screening
> forms and questionnaires; #3. You will need to have
> an interview with our psychologist over the phone;
> #4. You will need to schedule a physical with your
> doctor or one of ours in Boston if possible. If you
> are found eligible based on the results of your
> screening forms, physical exam and psychological
> evaluation, you will need to have a comprehensive
> eye exam with our neuro-ophthalmologist here in
> Boston.  In addition, you will need to review
> another research consent form with myself and
> another study representative, which we will be
> performed either in person or over the phone. 
> During this review session we will formally disclose
> the study procedures and what procedures we are
> asking you to perform during your participation. 
> If at this point you do not wish to participate you
> can withdraw your consent. However, you may withdraw
> your consent at any time during the study.  Signing
> either the screening consent form or the research
> consent form does not obligate you to screen,
> participate or complete this study.  Your signature
> only provides us with your written consent to start
> the screening and/or study procedures.  Your
> signature also indicates that we have informed you
> of all procedures, as well as the possible risks and
> benefits that accompany your participation.  You
> may ask questions at any time, and you may request
> counsel with one of our physicians regarding any
> medical or health concerns, issues or questions
> related to the study. Again, if you have any
> questions please feel free to contact me.  I have
> attached a copy of the initial questionnaire.  I,
> or my assistant, can also provide further details
> regarding procedures during inpatient visits as well
> as go over the initial questionnaire with you over
> the phone at a later date should you decide you
> would like to proceed.  Thank you for your time.
> Best regards,
> Joseph Hull
> Project Leader
> Division of Sleep Medicine
> Brigham and Women's Hospital
> 221 Longwood Avenue, BLI-438
> Boston, MA 02115Â  USA
> Phone: 1-888-828-4294
> Email: jhull at partners.org
> 
> 
> 
> THE FOLLOWING IS THE INITIAL QUESTIONNAIRE:
> Type your answers at the end of the question OR
> after the colon. You can mail or email this back to
> me.  Please be advised that e-mail is an unsecured
> median. If you do not wish to email sensitive
> information over e-mail please make arrangements to
> send via U.S. Post or your native postal carrier.
> 
> *Any personal and identifying information asked
> during this phone screen will need to be stored in
> the Division of Sleep Medicine Database. Do you give
> us permission to enter contact information in our
> Database? Yes or no?
> *If you are found ineligible, or are uninterested in
> this particular study, would you like to be informed
> about other studies in the future? Yes or no?
> 
> #1. Please give today's date:
> 
> #2. Please give your FIRST name ONLY:
> 
> #3. Please give your Email address:
> 
> #4. Please give your Phone number:
> 
> #5. Please give your Address:
> 
> #6. Please give your age and date of birth:
> 
> #7. How did you hear about the study?
> 
> #8. Have you ever done a research study before? If
> so, can you give details?
> 
> #9. Are you totally blind in both eyes?
> 
> #10. Do you have any conscious light perception in
> either eye?
> 
> #11. At what age and/or what year did you become
> totally blind in both eyes?
> 
> #12. What is the cause of your total blindness (if
> known)?
> 
> #13. Have one or both of your eyes been enucleated
> (removed)?
> 
> #14. Do you wear sunglasses, cosmetic scleral eye
> shells, or any type of protective eyewear?  Please
> explain?
> 
> #15. What is your height?
> 
> #16. What is your weight?
> 
> #17. Do you have any current medical illnesses or
> problems (if so please describe)? If female, are you
> currently pregnant?
> 
> #18. Do you have problems with your sleep (if so
> please describe)?
> 
> #19. Have you ever or do you currently use any
> sleeping pills?
> 
> #20. What is your usual wake time?
> 
> #21. Do you get up at a different time on some days?
> If so, when and why?
> 
> #22. What is your usual bedtime?
> 
> #23. Do you wake up in the night? If so how often,
> how long each time, why do you wake?
> 
> #24. Do you nap during the day? If so, how often do
> you nap, how long is your nap?
> 
> #25. Do you ever fall asleep without meaning to?
> 
> #26. Have you ever done night work or rotating shift
> work?
> 
> #27. If so, for each job how many days per week did
> you work nights, what were your work hours? For each
> job list what months and years you started and
> ended:
> 
> #28. Have you ever traveled to a different time
> zone? Where did you go? When did you come back?
> 
> The next set of questions will ask you about your
> past or current state of health. Please answer yes
> or no after the question mark. If you answer yes to
> any of the following medical issues below, please
> describe details, e.g., provide diagnosis, what
> treatment was given, is the condition ongoing?
> 
> #29. Have you had, or do you currently have heart or
> cardiovascular disease?
> 
> #30. Have you had, or do you currently have a heart
> murmur?
> 
> #31. Have you had, or do you currently have high
> blood pressure (also called hypertension)?
> 
> #32. Have you had, or do you currently have any
> endocrine disorders (such as thyroid disease)?
> 
> #33. Have you had, or do you currently have
> hepatitis?
> 
> #34. Have you ever received a hepatitis vaccination?
> 
> #35. Have you had, or do you currently have Asthma
> (what type of inhaler do you use)?
> 
> #36. Have you ever experienced Latex Sensitivity (if
> yes, what physical reaction did you experience?)?
> 
> #37. Have you had, or do you currently have Lung
> disease? (such as emphysema, chronic bronchitis,
> asthma)?
> 
> #38. Have you had, or do you currently have Kidney
> disease? (such as kidney failure, kidney infection,
> kidney stones)?
> 
> #39. Have you had, or do you currently have a
> Neurological disorder? (such as epilepsy, stroke,
> amnesia, migraine headaches, Parkinson's disease)?
> 
> #40. Have you ever suffered a head injury or loss of
> consciousness?
> 
> #41. Do you have Diabetes? (type 1 or type 2?)
> 
> #42. Have you had, or do you currently have a
> stomach or intestinal/digestive disorder? (such as
> ulcer, gastritis, gall bladder problems)?
> 
> #43. Do you have any hearing impairments?
> 
> #44. Have you ever received any psychiatric care or
> counseling?
> 
> #45. Have you ever been prescribed a medication from
> a psychiatrist?
> 
> #46. Do you have any family history of mental
> illness?
> 
> #47. Do you have any history of attempted suicide by
> yourself or a family member?
> 
> #48. Have you ever had any minor or major surgery?
> (What? When? Why?)
> 
> #49. Are you currently taking any of the following
> medications listed below? Please answer yes or no
> after the colon.
> Heart pill:
> Water pill (diuretic):
> Laxative:
> Sedatives (valium):
> Breathing pill:
> Sleeping pill:
> Health food supplement or herbal remedy (if so, what
> kind and what is it?):
> Pain pills, such as aspirin, Tylenol, Motrin (if so,
> why?):
> Circulation/blood pill:
> Antacid:
> Antihistamine:
> Birth control pill (female); if so what kind/brand:
> Acne medication:
> Any other pills, remedies or medications not
> mentioned? If so, what kind?:
> 
> #50. Do you currently or have you in the past used
> any of the following listed below? If yes, please
> describe details (when last used, how frequently)?
> 
> Marijuana:
> cocaine:
> amphetamines:
> Ecstasy:
> LSD, Mushrooms:
> Steroids (like D H E A, or Andro):
> cigarettes (if yes, how many per day?):
> Chewing tobacco:
> Cigars:
> Patches:
> 
> #51. How much coffee do you drink per day, per week,
> per month, or per year (whichever is the most
> common)?
> 
> #52. How much tea do you drink per day, per week,
> per month, or per year (whichever is the most
> common)?
> 
> #53. How many caffeinated soft drinks do you drink
> per day, per week, per month, or per year (whichever
> is the most common)?
> 
> #54. How much chocolate do you eat, or drink per
> day, per week, per month, or per year (whichever is
> the most common)?
> 
> #55. How many alcoholic drinks do you drink (please
> specify type, such as beer, wine, liquor, etc.) per
> day, per week, per month, or per year (whichever is
> the most common)?
> 
> You have now completed the initial questionnaire;
> thank you for your time.
> 
> 
> Study Description
> The following is the study description for a
> three-part study.
> Part 1: A 6-day study while you live in our
> laboratory
> Part 2: An 8 to16 week study while you live at home
> Part 3: A 15 or 28-day study while you live in
> laboratory
> Study Coordinator: Joseph Hull
> jhull at partners.org
> 
> We are currently seeking healthy, totally blind men
> and women ages 18-70 to participate in a home and
> laboratory research study.  The study consists of
> two laboratory visits that are separated by an eight
> to sixteen week home-based field study.  The
> purpose of this study is to increase knowledge about
> the human biological clock.  The knowledge gained
> from this study may improve the health, productivity
> and safety of not only totally blind individuals,
> but also those with a high prevalence of insomnia,
> such as shift workers and the elderly.
> 
> Prior to entering the study we will ask you to
> complete a screening process, which involves filling
> out screening forms, having a physical exam with a
> physician, blood and urine tests, having an
> ophthalmological eye exam and completing an
> assessment with our staff  psychologist.  The
> screening can be completed in up to three to five
> visits.
> 
> In order for the study to achieve the highest
> quality results you will be asked to participate in
> both a home-based outpatient protocol and two
> inpatient protocols, which will require two visits
> to the hospital.  You will first remain in the
> hospital for your inpatient visit #1 for the
> duration of 6 days.  Upon completing the initial 6
> days, you will return home for an 8 to 16-week
> home-based outpatient protocol.  The length of your
> home-based protocol will be determined in the first
> few weeks after starting home-based protocol. Upon
> completing the home-based protocol, you will return
> to the hospital for your inpatient visit #2.  Your
> inpatient visit #2 will be either 15 or 28 days in
> duration.  The length of your inpatient visit #2
> will be determined by the results obtained during
> inpatient visit #1.  During each inpatient visit,
> we will request that you not leave your suite until
> the completion of the inpatient protocol.  This is
> unless you choose to withdraw from the study, which
> is your option at any point (see payment section
> below).
> 
> Inpatient Study Conditions
> Environment free of time cues:Â  The study seeks to
> create an environment free of time cues.  Anything
> that might give study participants a time cue is
> prohibited.  This means that there are no windows
> in your suite as well as no watches, clocks, live
> TV’s, radios, phone calls or visitors, although
> you will have frequent interaction with the research
> staff and you are able to listen to tapes and
> CD’s.
> 
> Constant Routines: For 3 to 5 times during the study
> you will be asked to participate in a procedure
> called a constant routine. This procedure will
> require you to remain in bed, awake, and relatively
> inactive for up to 20-70 hours. You will be given
> the opportunity to sleep between these periods of
> extended wakefulness. We will monitor your brain
> waves continuously during these constant routines,
> and proportioned snacks will be provided
> periodically, such that your overall daily caloric
> intake