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| Studies for Veterans and Civilians |
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 Benefit/Risk |
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There is no benefit for taking part in this study.
The information we get during this study may help us to identify how sleep affects the brain circuits involved in emotions.
As with any experimental study, there may be adverse events or side effects that are currently unknown and it is possible that certain of these unknown risks could be permanent, serious or life-threatening. Overall, this study involves moderate risks. The possible risks from this study may be due to the sleep disruption, the laboratory sleep studies, the brain scanning session, discomfort from the mild, brief electric shocks, or from a breach of confidentiality.
*Risks from sleep disruption: Both sleep deprivation or sleep restriction are likely to be associated with sleepiness and may be associated with some mild mood changes in healthy participants.
*Risks from the laboratory sleep studies: Some people may develop a skin irritation from the placement or removal of scalp, chin, or eye electrodes, tape, or paste used during the sleep studies. This irritation quickly disappears, but if it bothers you, a steroid ointment such as the kind you buy in the drugstore can easily take care of this problem.
*Risks from the MRI (Infrequent: experienced by 1-10% of participants or 1 to 10 of 100 people): You may experience claustrophobia (fearfulness or nervousness when being in an enclosed space). If you experience a fear of the confined space while in the magnet, you can end the study. Noises made by the machine may be bothersome.
There are no known risks or side effects of the magnetism or radio waves used in MRI. There is the potential risk related to the machine itself attracting metal. The MR. procedure could result in movement of any metal objects in the body, and this movement could result in serious injury. Therefore, if you have metal within your body you will be excluded from the study. Examples of metal objects which may be in a person’s body are: heart pacemaker, aneurysm clip (a metal clip from certain surgeries), ear implant, Intra Uterine Device (IUD), shrapnel (metal from an exploded bomb in combat or from grinding metal objects), neurostimulator (a nerve simulator used to treat pain) or other metal devices. Pregnancy and fear of closed spaces also exclude you from this study. Dental fillings do not present a problem. No other serious side effects have been reported from being inside a magnet. However, if the noise of the MR machine makes you uncomfortable, we can provide you with sound-muffing headphones while in the scan.
*Mild FingerShock: A mild finger shock will be administered to two fingers. You will choose a level that is unpleasant, but not painful, prior to beginning the experimental procedures. The level that you set will be used throughout the remainder of the experiment.
*Breach of confidentiality: It is possible that information from your participation will be discovered by individuals other than personnel working on this study, despite our careful steps to protect your confidentiality. Maintaining strict security on information that you provide will minimize these risks. Study data will be kept strictly confidential and participants’ identities will not be revealed in any publication. All participants have subject numbers that will be used on forms and for data storage purposes. The PI will have locked files linking participants’ names and identification numbers. No results will be released to employers. All information will be kept in locked files and access to these materials will be limited to study personnel and those involved in the clinical care of participants. Computer databases are protected by several procedures, including password protection of subject data and a firewall around the entire Research Computing Network in the N-CTRC at the University of Pittsburgh.
Representatives of the U S Army Medical Research and Materiel Command (USAMRMC) are authorized to review research records as part of their responsibility to protect human research volunteers. For military personnel, complete confidentiality cannot be guaranteed because information bearing on a soldier’s health may be required for report to appropriate medical or command authorities
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