28-Day Study in Short and Long Sleepers

28-Day Study in Short and Long Sleepers: Information for Interested Individuals

Greetings from the Division of Sleep Medicine of Brigham & Women’s Hospital: Thank you very much for inquiring about the sleep research studies here at Brigham and Women’s Hospital. We are currently seeking healthy men and women ages 18-35 to participate in a 28-day long research study. Please read on for more information regarding this study. If you are interested in participating, you may fill in the questionnaire attached to this study description. Please note that email is NOT a secure document, and should you not want to send your personal information over email, you may call us at 617 732 7917 to answer the questions over the phone.

The purpose of the study is to see what determines how much sleep a person needs. To do this, we will study people who regularly sleep for a long time or a short time each day. We hope to learn what biological factors (things in the body) determine how much time a person sleeps.

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), an assessment with a psychologist, and an overnight stay in a sleep laboratory. The screening can be completed in 4-6 visits over a period of several weeks.

If you are found eligible and choose to participate in this study, you will be asked to remain at the hospital in your own private suite for the duration of the 28 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.

During all portions of the study, we will schedule all your daily activities (eating, sleeping, etc.) in a regular manner. A typical day will include a breakfast, a shower, a lunch, a dinner and a snack, and may include collection of biological samples (blood, urine, and saliva), electroencephalographic monitoring (i.e. recording of the brain waves), and tests of alertness and cognitive performance. Constant Posture: On two occasions during the study, you will be asked to be on a Constant Posture in which you are asked to remain sitting in bed and relatively inactive for 32 to 64 hours. At scheduled times you will be given a sleep opportunity. During these times it will be dark in the room. During a portion of one of the two Constant Postures you will be asked to stay awake continuously for 32-40 hours.

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 four 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 actiwatch 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): During nights and days, your sleep and waking brainwaves will be recorded with an EEG. 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 and remove yourself.

-Blood Drawings: During certain segments of the study, small blood samples will be collected through a very thin plastic tube (an IV catheter) at frequent intervals for hormonal analysis. The total amount of blood lost over the entire length of the study will be approximately 1.5 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 spit a small amount of saliva into a test tube so that we can collect salivary hormone samples.

-Urine Samples: At different times during the study urine will be collected. This allows us to monitor specific hormones in your systems

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:

 Alcohol  Caffeine Products (coffee, tea, soft-drinks, chocolate)  Nicotine  Prescription or non-prescription (over the counter) drugs i.e. patches, vitamins, or steroidal creams  Poppy seeds  Recreational or Street Drugs  Other foreign substances  Food other that 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 diary: $25/week (3 weeks) Wearing actiwatch: $25/week (3 weeks) Returning actiwatch: $25 one time Overnight sleep recording: $50 one time In-study at the hospital: $130/day Completion bonus: $300/week inpatient stay (pro-rated) ______Total = up to $5,090

Payment is in the form of one check approximately 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. In the future, other people, for instance people with certain sleep disorders may benefit from the information learned in this study.

If you are interested in participating in this study, please call us at 617 732 7917, or fill out the attached questionnaire and e-mail it to [email protected] with ‘Short & Long Sleeper Study’ in the subject heading.