Medical Testing, 9 day sleep study

Renork · RealPoor Master of Posts Joined: 23 Jun 2003 Posts: 6282

Has anyone here done medical testing shit before and if so how was your experience with it?? If anyone is bored and feels like reading all of this mind giving me your opinion on the potential_suck vs payout ratio?

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9 DAY SLEEP AND CIRCADIAN RHYTHM RESEARCH STUDY
INFORMATION FOR INTERESTED SUBJECTS
Subject Coordinator: Lisa McCaig (617) 732-4311

The purpose of this study is to evaluate how light exposure affects our biological clock: our hormones, body temperature, alertness, performance and sleep. The study is being done in order to help people sleep better and to test whether different intensities of light are effective in improving sleep quality. This is an inpatient study, so all of your time will be spent in your suite. You cannot leave the suite until the end of the 9 day period unless you decide to withdraw from the study.

The information presented here is subject to change but will always be consistent with the information provided in the research consent form available from your coordinator. Be sure to ask the coordinator for clarification of any of the information presented below and in the consent form.

1. WHAT YOU WILL DO
We are looking for healthy individuals 18-30 years old only.
With this study you will have free time. You may read, do hobbies, listen to music or work on a personal project. However, be aware that your free time will be interrupted frequently with mandatory computer testing, and all activities study related will be scheduled for you. On 2 occasions, you are asked to remain awake for 20-70 hours lying in bed the entire time. This is called a Constant Routine. A technician will be there to entertain you, play games, and assist you in staying awake when you need it.

2. WHAT WE MONITOR
For several weeks prior to being studied in the laboratory, your sleeping patterns will be monitored several ways. This includes a wrist activity recorder (actiwatch), which measures your activity and movement during the day and night, as well as you keeping a log of your sleep/wake times (this requires call-ins every night and morning to a voice-mail system). Once you are admitted to the hospital, we will record your sleep patterns, take blood samples, urine samples, and saliva samples. Throughout your stay here there are two video cameras in your room. They are used to help the technicians monitor your well being and to make sure that you are staying awake when you say you are. However, at no time are you being recorded on video or audiotape.

PRESTUDY SCREENING:
In order for us to determine if you are eligible for the study you will need to go through a screening process. This consists of multiple visits to my office to:
Fill in paperwork
Have a physical, an EKG and lab work (a blood and urine sample)
We will have to contact your PCP to obtain any major medical records of treatments/non-routine visits
Meet with our psychologist for a routine assessment
Meet with the Doctor that runs the study to discuss in-study procedures/rights of a volunteer
After these are completed (or while you are working on them) we will need you to keep a regulated 8-hour sleeping schedule for 3 weeks immediately prior to you starting the study. You will be able to pick your own 8-hours but they must stay the same over the 3 weeks. You keep track by calling into a voice-mail system every night and every morning at the times you go to sleep and the times you wake up. As the 3rd week is starting, you will be given the wrist activity recorder mentioned in the paragraph above. You admission to the study is directly related to how well you maintain (or try to maintain) this schedule.

There are no other options to these steps, except to not do the study.

DURING THE STUDY:
*Electroencephalogram: Every night your sleep will be monitored with an EEG, recording your brain waves. 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 the scalp, face chin, and some are held in place with special glue that will shampoo out.

*Temperature: Your body temperature is monitored constantly during your stay here. This is done using a rectal temperature sensor. This sensor is a very thin, very flexible piece of wire that is coated in plastic. You will wear it for the entire length of the study, except for when having a bowel movement of having a shower.

*Blood Drawings: During your stay in the lab, you will have an IV catheter that will draw small amounts of blood at various times. This is for hormonal analysis. The total blood lost over the entire length of the study is 2 pints. A very small amount of Heparin (an anti coagulant) will run through the IV to prevent clotting in the tube.

*Urine Samples: Throughout the entire study, urine will be collected.

*Saliva Samples: During certain portions of the study, saliva is collected by asking you to spit in a small test tube.

RESTRICTIONS:
Dietary Restrictions. The following substances are prohibited throughout the course of the study, from the time of the screening evaluation until the completion of the three-week post-study sleep/wake log:
Alcohol
Caffeine (frequently found in coffee, tea, soft drinks, dark and white chocolate, etc.)
Nicotine (tobacco products of any kind)
Prescription or non-prescription (over-the-counter) drugs
Recreation/street drugs
Other foreign substances
**If in doubt about a particular substance, ask before taking.

Time Isolation Restrictions: Again this study involves spending 9 days and 8 nights living in a lab. That means you cannot leave the room. You will not know what time of day it is. This is so that your knowledge of what time of day it is does not effect how you are feeling at any particular time. 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. As there are no time cues allowed during the study, there are no windows in the suites. In addition, no watch, clocks, TVs, radios, visits or phone calls are allowed in order to maintain a time free environment.

COGNITIVE PERFORMANCE BATTERY:
During the study, you will perform several performance tests. The tests are presented on a computer. You respond to these tests by using a trackball, the keys on the computer keyboard, or a two-button response pad. The performance tests are of several types, testing for reaction time, memory, hand-eye coordination, math and your mood at that time. Most people are surprised at the frequency and the repetition of computer testing, so please realize that this will take up a lot of your time.

CONSTANT ROUTINES:
The constant routine is considered by some to be the most difficult part of the study. During this time we will ask you to remain awake while sitting in bed for anywhere between 20-70 hours. We realize that this is a very long time to be awake, so we give you a person to talk with, play games with and do anything they can do to help you through it. Also note that we give you this range " 20-70" hours because your constant routine may be ANYWHERE in that range. During this time your brain waves are monitored (using encephalographic monitoring), along with frequent blood drawings. Periodically you will participate in short computer testing. You will be fed small frequent snacks throughout the constant routine, so your daily overall daily caloric intake will be equal to the amount of food you would receive in three meals and a snack.
Since you are not allowed out of bed, you would have to use a bed pan or urinal during this time.
This occurs two separate times throughout the study.

LIGHT TREATMENT:
For most of the study, the lighting may seem rather dim, averaging 5-50 lux, during the time you are awake.
Because the lights are at the dim level, you would not be allowed to watch movies as the TV monitor throws off more light levels than needed. It is perfectly reasonable to read in this light without straining your eyes.
When it is time for you to go to bed, the lights will be turned out, and it will be complete darkness until the scheduled time for you to wake up.

On 1-3 occasions you may be exposed to a bright indoor light that would last for 1-9 hours. If you receive this bright light exposure you may be asked to look at a specific point marked out for you in order to ensure that you are getting the maximum exposure of light. You will be given mini-breaks during these sessions, but will not know how long you have done it for or how long you have left to finish.

PAY:
Payment begins once you have completed the paperwork and begun your regular
Sleep/wake schedule. When this commences, you are paid $25.00/ week for
call-ins. This increases to $50.00/ week when you receive the actiwatch.
Realize though, that at any time you may be screened out. If this happens,
then you will be paid for what you have completed.

Payment is broken as such:
1st week of call-ins: $25/ week
2nd week of call-ins: $25/ week
Physical/ Lab work: $25/ week
3rd week of call-ins/ actiwatch $50/week
Daily pay while in research lab: $120/day
Incentive bonus while in study: $70/day
*payable only if study completed
Return Actiwatch $25/ one time

Payment upon full completion $1,860

Payment is in the form of one check about 4 weeks after 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 $70/day completion
bonus is paid. Also, there is no monetary compensation paid to any person
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 may reveal some medical abnormality. This information will be
conveyed to you at once, together with a recommendation to a local clinic
or physician.

There are no lingering effects of this study, although it may take your
body a day or two to adjust to its normal schedule after having been awake
(as if you had jet lag).

Medical Testing, 9 day sleep study

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