|
|
| Studies for Veterans and Civilians |
| |
 Purpose of Study |
| |
| |
| Research has shown that sleep disruption may contribute to poor psychological health following a traumatic experience. This study seeks to examine how short term sleep loss affects emotional processing in healthy individuals who may or may not have served in the military. The study also considers factors such as genetic influences and past experiences. Understanding how sleep loss affects emotional processing in the brain will help researchers better understand the mechanisms that may contribute to disorders such as Posttraumatic Stress, depression, and addiction. This may enable researchers to find effective preventative and treatment interventions. |
| |
| |
to top |
|
|
| |
| Who May Participate |
| |
| |
We are looking for men and women who:
• Are veterans or civilians
• Are 18-30 years old
• Are right handed
• Have good physical and psychological health
• Have good sleep
• Are not pregnant or breastfeeding
|
| |
| |
to top |
|
|
| |
| Study Procedures |
| |
| |
All procedures will take place at Western Psychiatric Institute and Clinic on O’Hara Street in Oakland. Our address is 3811 O’Hara St., Pittsburgh, PA 15213. Parking is provided.
Phase 1
_________________________________________________________________________________
Visit 1: Complete screening questionnaires to determine if you are eligible to participate and provide a blood sample for genetic analysis. (45-60 minutes)
Visit 2: Complete a medical evaluation and an in-person interview to ensure that you meet eligibility criteria to participate. (2 hours) If eligible, you will then receive a small portable device called an ApneaLink to monitor your breathing during sleep for one night at home. You will also receive a sleep diary and an actigraph wristwatch (which monitors sleep and wakefulness) to record your regular sleep schedule for 7-10 days.
Visit 3: Review the results of your at-home sleep monitoring and receive a new actigraph wristwatch to continue monitoring your sleep for another 7-10 days. (45-60 minutes)
Phase 2
_________________________________________________________________________________
Night 1: Sleep overnight according to your normal routine in our sleep laboratory. In the morning you may leave for the day and return in the evening. (1 night)
Nights 2-3: Stay overnight in our sleep laboratory. You will be randomly assigned to one of the following three conditions for Night 2:
• Sleep undisturbed according to your normal routine
• Sleep for the first half of the night, then remain awake for the second half
• Remain awake for the entire night
After completing Night 2, you will spend the following day in our laboratory and will remain awake until your normal bedtime. You will then sleep undisrupted through Night 3, according to your normal routine. This means that the longest amount of time you may be asked to remain awake is approximately 38 hours, if you are assigned to remain awake for all of Night 2. (2 nights, 1 day)
Throughout Phase 2, you will be asked to complete 4 fMRI scans that will record your brain activity while you engage in various mental tasks.
About the fMRI tasks:
You will be asked to perform challenging mental tasks on a computer. While you complete the tasks, we will record your heart rate, pupil dilation, skin conductance (sweat), and brain activity using a procedure called functional magnetic resonance imaging (fMRI). An fMRI scan is a test that produces images that are similar to x-ray pictures. We use fMRI to help improve our understanding of the way the brain works when people are feeling different emotions. This method should lead to better treatment for emotional disorders in the future. fMRI uses a large magnet and does not use any radiation.
The magnet used for fMRI is a large tunnel-like machine. You will lie on a table that will move you into the tunnel for a maximum of 1 hour for each of the 4 testing sessions. You will be asked to lie still without moving during the scan. The scanner makes loud, banging sounds during the study, but you will be wearing protective earplugs. You will be able to talk to and hear the replies of the technician who is performing the test. Because you must lie with your head and neck inside the narrow scanner tube, or gantry, you may become anxious and frightened in the enclosed space. Some participants may experience claustrophobic feelings, or fear of enclosed spaces, while in the scanner. If you feel claustrophobic during the scan or for any reason feel that you cannot tolerate remaining in the scanner, the study can be interrupted and you will be able to rest outside of this enclosed area or to terminate the procedure if you choose to do so.
******You may choose to immediately stop this session at any time by alerting the technician using a hand signal and/or squeezing the red ball that we will show you******
After you are done with the experimental procedures in the morning following Night 3, a staff member will meet with you to review the study results with you. Your participation in the research study will then be completed, and you will be free to leave the sleep laboratory.
|
| |
| |
to top |
|
|
| |
| Scheduling Visits |
| |
| |
We make every effort to accommodate your schedule with our offices, sleep lab, and MRI center. Study procedures can be completed in 2-4 weeks, requiring a minimum of 5 visits.
Phase 1:
Visits 1-3 can be scheduled Monday through Friday, 8:30am-4pm.
Phase 2:
Nights 1-3 must be completed consecutively and can be scheduled Tuesday through Friday nights. This means you must be able to stay in our lab all day on either Wednesday or Friday.
|
| |
| |
to top |
|
|
| |
| Compensation |
| |
| |
At the end of Visit 1, you will receive $10 for completing all of the necessary procedures.
At the end of Visit 3, you will receive $35 for completing the at-home sleep monitoring with the ApneaLink, sleep diary, and actigraph wristwatch.
In the morning following Night 3, you will receive $150 for completing Phase 2. In addition, you will have the chance to win up to $120 during the fMRI tasks.
This means that the total compensation for completing all procedures is $195 plus up to an additional $120.
We will also provide you with free parking and free meals during all of your stays in the lab.
|
| |
| |
to top |
|
|
| |
| Confidentiality |
| |
| |
| All information collected throughout the research process will remain strictly confidential. No information that you provide to us will become a part of your medical or military record. Your personal information (such as your name and birth date) will be stored separately and securely from the information we collect about you for the study. This information will only be labeled with a 6 digit ID number. |
| |
| |
to top |
|
|
| |
| Benefit/Risk |
| |
| |
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
|
| |
| |
to top |
|
|
| |
| |
|
