73 day sleep study
13 December 2003 15:16![[personal profile]](https://www.dreamwidth.org/img/silk/identity/user.png){kind=small}
juldeaWe are currently seeking healthy men and women ages 20-50 to participate in
a 73-day research study. The purpose of this study is to increase knowledge
about how the human biological clock keeps time with a 24-hour day. The
knowledge gained from this study may improve the health, productivity and
safety not only of astronauts during space flight, but also of other groups
with a high prevalence of insomnia, such as shift workers and the elderly.
Prior to entering the study we will have you go through a screening
process, which involves paperwork, a physical, lab work (blood and urine
samples) and an assessment with a psychologist. The screening can be
completed in three to four visits.
In order for the study to achieve the highest quality results you will be
asked to remain at the hospital in your own private suite for the duration
of the 73 days. We will request you to not leave your suite until the
completion of the study. This is unless you choose to withdraw from the
study, which is your option at any point (see payment section below).
Study Conditions
Environment free of time cues: 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. The purpose of this is to prevent your
knowledge of time from influencing how you feel at a particular moment. For
example: If we ask you if you are sleepy and you know that it is 11pm, you
are more likely to say that you are sleepy than if we asked you at 11am.
Constant Postures: For up to 5 times during the study you will be asked to
participate in a procedure called a constant posture. This procedure will
require you to remain in bed, awake, and relatively inactive for 24-48
hours. You will be able to sleep during scheduled portions of the constant
posture.
Cognitive Performance Battery: During the study you will frequently take a
variety of performance tests. The tests are presented on a computer. You
respond to these tests by using a trackball, 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, hand-eye coordination,
simple math skills and your current mood.
Free Time: During the study you will have significant amounts of free time
during which you may read, write, draw, paint, 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 three weeks prior to entering the study, your sleeping
pattern will be monitored. You will wear a wrist activity recorder
(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. You
will also need to keep a logbook at home regarding your sleep/wake schedule
as well as call in your sleep and wake times to your recruiter every morning
and night.
During the study the following will be performed:
-Electroencephalogram (EEG): Every night and day your sleep and waking
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 a 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.
-Temperature: 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 an
remove yourself. However, there will be periods throughout the study when
it will not be necessary to wear the sensor to monitor body temperature.
-Blood Drawings: 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 blood loss over the entire length of the
73-day study will be approximately 50 ounces (a little more than 3 pints),
and will be spread out throughout the study. 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
spit a small amount of saliva into a test tube so that we can collect
salivary hormone samples.
-Urine Samples: Throughout the entire study urine samples will be collected
at frequent times. This allows us to monitor specific hormones in your
system.
Restrictions
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 than that provided by our dietary staff (while in the actual
study)
*If in doubt about a particular substance, please ask before taking it.
Payment
Physical: $25 one time
Maintaining a regular sleep-wake schedule $25/week (up to four weeks)
Wearing actiwatch $25/week (for three to five weeks)
Returning actiwatch $25 one time
In-study at the hospital $100/day
Completion bonus $300/week inpatient stay (pro-rated)
______________________
Total= up to $10,629
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 $300/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.
73-Day Study Questionnaire :
Name
Address
Phone number
Email
Age & date of birth
how did you hear about this study?
What is your current occupation?
Have you ever done a research study before? (if yes, please describe)
When would you be able to participate in this study?
Do you have any medical illnesses or problems?
Height? Weight?
Have you ever or do you now have....answer yes or no
Heart disease or heart murmur?
lung disease?
kidney disease?
visual or hearing impairment?
eye injuries?
color blindness?
neurological disease ( ex.stroke, seizures)?
stomach or intestine disease ( ex.ulcers)?
accidents/head injuries/loss of consciousness? (please describe if any)
thyroid disease?
high blood pressure?
diabetes?
hepatitis?
hepatitis vaccination?
asthma?
surgery (please describe)?
psychiatric care or counseling?
mental illness in family?
history of attempted suicide in yourself or your
family?
Are you currently taking any medications?
Have you ever taken Accutane, Tetracycline, Oral Retin-A or any other
prescribed anti-acne medications?
(acne medications, if so
Date started medication______ Date ended medication________
was it oral or topical?
How many times per day or per week do you have the
following?
coffee
tea
caffeinated soft drinks
chocolate
alcoholic drinks (which kind)
sedatives (valium or other anti-anxiety agents)
antihistamines (allergy meds.)
aspirin, Tylenol or other pain relievers?
health food supplements
Antacids
Do you currently or have you ever used the following
(if so when was the
most recent time and how many times in life)
Marijuana?
Ecstasy?
Cocaine?
Amphetamines (uppers)?
Sleeping pills?
LSD, mushrooms?
Other?
Do you smoke? How much?
Do you have any problems with your sleep, if so what
kind of problems and
how frequently?
usual bedtime on weekdays? weekends?
usual waketime on weekdays? weekends?
Can you keep a regular 8 hour sleep schedule for 3 weeks
prior to study ?
When was the last time you stayed up all night?
Have you traveled outside the time zone within the
past three months?
if so, where?
when did you return?
Have you ever worked the night shift for ex 11:00
pm-7:00am?
how many days/week? what days? what hours?
date started?
date finished?
Do you wish to be contacted about future studies?
FOR WOMEN PARTICIPANTS:
Do you have regular periods?
Days between cycles?
Date of last menses?
Menses prior to that?
Have you ever used birth control?
Type?
From__________ to __________________
a 73-day research study. The purpose of this study is to increase knowledge
about how the human biological clock keeps time with a 24-hour day. The
knowledge gained from this study may improve the health, productivity and
safety not only of astronauts during space flight, but also of other groups
with a high prevalence of insomnia, such as shift workers and the elderly.
Prior to entering the study we will have you go through a screening
process, which involves paperwork, a physical, lab work (blood and urine
samples) and an assessment with a psychologist. The screening can be
completed in three to four visits.
In order for the study to achieve the highest quality results you will be
asked to remain at the hospital in your own private suite for the duration
of the 73 days. We will request you to not leave your suite until the
completion of the study. This is unless you choose to withdraw from the
study, which is your option at any point (see payment section below).
Study Conditions
Environment free of time cues: 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. The purpose of this is to prevent your
knowledge of time from influencing how you feel at a particular moment. For
example: If we ask you if you are sleepy and you know that it is 11pm, you
are more likely to say that you are sleepy than if we asked you at 11am.
Constant Postures: For up to 5 times during the study you will be asked to
participate in a procedure called a constant posture. This procedure will
require you to remain in bed, awake, and relatively inactive for 24-48
hours. You will be able to sleep during scheduled portions of the constant
posture.
Cognitive Performance Battery: During the study you will frequently take a
variety of performance tests. The tests are presented on a computer. You
respond to these tests by using a trackball, 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, hand-eye coordination,
simple math skills and your current mood.
Free Time: During the study you will have significant amounts of free time
during which you may read, write, draw, paint, 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 three weeks prior to entering the study, your sleeping
pattern will be monitored. You will wear a wrist activity recorder
(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. You
will also need to keep a logbook at home regarding your sleep/wake schedule
as well as call in your sleep and wake times to your recruiter every morning
and night.
During the study the following will be performed:
-Electroencephalogram (EEG): Every night and day your sleep and waking
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 a 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.
-Temperature: 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 an
remove yourself. However, there will be periods throughout the study when
it will not be necessary to wear the sensor to monitor body temperature.
-Blood Drawings: 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 blood loss over the entire length of the
73-day study will be approximately 50 ounces (a little more than 3 pints),
and will be spread out throughout the study. 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
spit a small amount of saliva into a test tube so that we can collect
salivary hormone samples.
-Urine Samples: Throughout the entire study urine samples will be collected
at frequent times. This allows us to monitor specific hormones in your
system.
Restrictions
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 than that provided by our dietary staff (while in the actual
study)
*If in doubt about a particular substance, please ask before taking it.
Payment
Physical: $25 one time
Maintaining a regular sleep-wake schedule $25/week (up to four weeks)
Wearing actiwatch $25/week (for three to five weeks)
Returning actiwatch $25 one time
In-study at the hospital $100/day
Completion bonus $300/week inpatient stay (pro-rated)
______________________
Total= up to $10,629
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 $300/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.
73-Day Study Questionnaire :
Name
Address
Phone number
Age & date of birth
how did you hear about this study?
What is your current occupation?
Have you ever done a research study before? (if yes, please describe)
When would you be able to participate in this study?
Do you have any medical illnesses or problems?
Height? Weight?
Have you ever or do you now have....answer yes or no
Heart disease or heart murmur?
lung disease?
kidney disease?
visual or hearing impairment?
eye injuries?
color blindness?
neurological disease ( ex.stroke, seizures)?
stomach or intestine disease ( ex.ulcers)?
accidents/head injuries/loss of consciousness? (please describe if any)
thyroid disease?
high blood pressure?
diabetes?
hepatitis?
hepatitis vaccination?
asthma?
surgery (please describe)?
psychiatric care or counseling?
mental illness in family?
history of attempted suicide in yourself or your
family?
Are you currently taking any medications?
Have you ever taken Accutane, Tetracycline, Oral Retin-A or any other
prescribed anti-acne medications?
(acne medications, if so
Date started medication______ Date ended medication________
was it oral or topical?
How many times per day or per week do you have the
following?
coffee
tea
caffeinated soft drinks
chocolate
alcoholic drinks (which kind)
sedatives (valium or other anti-anxiety agents)
antihistamines (allergy meds.)
aspirin, Tylenol or other pain relievers?
health food supplements
Antacids
Do you currently or have you ever used the following
(if so when was the
most recent time and how many times in life)
Marijuana?
Ecstasy?
Cocaine?
Amphetamines (uppers)?
Sleeping pills?
LSD, mushrooms?
Other?
Do you smoke? How much?
Do you have any problems with your sleep, if so what
kind of problems and
how frequently?
usual bedtime on weekdays? weekends?
usual waketime on weekdays? weekends?
Can you keep a regular 8 hour sleep schedule for 3 weeks
prior to study ?
When was the last time you stayed up all night?
Have you traveled outside the time zone within the
past three months?
if so, where?
when did you return?
Have you ever worked the night shift for ex 11:00
pm-7:00am?
how many days/week? what days? what hours?
date started?
date finished?
Do you wish to be contacted about future studies?
FOR WOMEN PARTICIPANTS:
Do you have regular periods?
Days between cycles?
Date of last menses?
Menses prior to that?
Have you ever used birth control?
Type?
From__________ to __________________
![[identity profile]](https://www.dreamwidth.org/img/silk/identity/openid.png){kind=small}
no subject
on 13 Dec 2003 13:14 (UTC)All we need to do is give you the appropriate entertainment.
no subject
on 13 Dec 2003 15:44 (UTC)I want to find five of these a year and be paid a $50000 salary (plus room and board) for the terrible hardship of living in a near-perfect environment for writing.
no subject
on 13 Dec 2003 15:53 (UTC)THAT would be cool.
no subject
on 13 Dec 2003 20:59 (UTC)It worked for Emerson, didn't it?
no subject
on 13 Dec 2003 20:58 (UTC)In fact, I'm probably really ideal in that sense, because I've only made a few friends in Boston here so far. And I don't see those friends that often.