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 Background Information |
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Sleep disturbances and sleep deprivation are common during military training, operations, and deployment.
For some military service members, sleep disturbances disappear after returning home from a military deployment. For others, sleep disturbances continue even after coming home.
In this study, we are looking to understand how the sleeping brain differs in combat exposed military veterans who are good sleeps from military veterans who have sleep disturbances associated with pots-traumatic stress reactions that continue after deployment.
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| Study Procedures |
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***Phase 1:***
Screening Phase, we ask people to complete questionnaires, interviews, and medical tests. To verify your eligibility and safety to participate in this study. The procedures are done up to 3 visits:
-face-to-face meeting to complete interviews and questionnaires
-physical examination and MRI scan
-sleep screening study. This last step involves sleeping in the laboratory for one entire night for a Sleep Apnea evaluation
***Phase 2:***
After completing the screening procedures, eligible participants will sleep in the laboratory for 2 consecutive nights of EEG sleep studies, one waking [18F]-FDG PET scan, and one REM sleep PET scan according to published methods. EEG and PET studies will take place in the NCTRC laboratory at WPIC, and in the PET facility of the University of Pittsburgh Medical Center, Presbyterian Hospital. Night 1 will serve as the baseline night. Night 2 will be used for the REM sleep scans. On Day 1 and Day 2, participants will be free to go after morning procedures are completed (e.g., removing electrodes, waking scan on Day 2) and will return to the laboratory at 20:00 in the evening for the next study night. On each night upon arrival to the sleep laboratory, participants will be required to provide a urine sample to verify the absence of drug use. Participants will also be required to take a breathalyzer test in order to verify blood alcohol level of 0.0.
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| Timeline |
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The total duration of the study is up to three weeks to accomodate participant's schedules, laboratory, and PET center schedules
Phase 1: Screening Phase-up 2 weeks for interviews, lab work, and MRI
Phase 2:Sleep Screenings and Pet Scans 1 week |
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| Confidentiality |
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Every effort will be made to make sure that the information about you obtained from this study will be kept strictly confidential.
During the course of this research study, we collect private information such as your name, laboratory values regarding blood cell counts, drug and alcohol use, physical exams (blood pressure, height, weight, health condition), and other medical information of past and current physical and mental health and behaviors. Private health information will be kept until your participation in the study is completed, or 6 years following the end of the research study, whichever is later.
To help us protect your privacy, we have applied for a Certificate of Confidentiality from the National Institutes of Mental Health as of 2 April 2009. With this Certificate, the researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. The researchers will use the Certificate to resist any demands for information that would identify you, except under certain circumstances that will be explained to you in detail at your first visit |
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| Benefit/Risk |
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Some participants may benefit from the sleep evaluation. The information we get during this study may identify medical conditions that you or your doctor did not know about. It is also possible that you will derive no direct benefit from your participation. Your participation in the study will help us to identify brain activity patterns during sleep that may be related to the development and persistence of PTSD in military veterans.
As with any research 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. The possible risks from this study may be due to the laboratory sleep and PET studies, the MRI, obtaining blood samples, completing the in-person interviews and questionnaires, or from a breach of confidentiality.
Risks from the PET studies (Likely: occur in more than 25% of participants): Participation in this research study involves exposure to low-level radiation from the PET transmission scans and the administered 18F-FDG. Over the entire study, you will receive 2 (5 mCi) injections of 18F-FDG and 2 transmissions scans; resulting in whole body radiation exposure of 1.10 rems ( a rem is a unit of radiation dose). For comparison, this is approximately 25 % (1/4) of the maximum annual whole body radiation dose (5 rems) permitted to radiation workers by Federal regulations. There is no known minimal level of radiation exposure that is recognized as being totally free of the risk of causing genetic defects (changes that damage your body’s ability to reproduce new cells) or cancer. However, the risk associated with the amount of radiation exposure that you will receive from this study is considered low and comparable to other everyday risks. You will be asked to drink fluids and to urinate frequently after each PET scan sessions to further reduce your radiation exposure.
Risks from obtaining blood samples (Common: occur in 10-25% of participants): Blood samples will be drawn by venipuncture (a small needle inserted into your vein). Likely risk of venipuncture (experienced by more than 25% of participants) includes pain. Bruising at the site of the needle insertion is commonly experienced by 10-25% of people who participate. Dizziness, bleeding, and infection at the site of the blood draw are infrequent risks (experienced by 1-10% of people). Fainting and whole-body infections are rare risks, occurring in less than 1% of people who participate in these procedures.
We will reduce these risks by having trained staff take the samples under disinfected (sterile) conditions. Blood samples will be drawn by venipuncture (a small needle inserted into your vein). The total amount of blood withdrawn in this study will be 42 milliliters (ml), or less than 10 teaspoons divided among two occasions: 30ml [6 teaspoons] at the physical examination, and 6 ml (less than 2 teaspoons) during each of the 2 PET scan sessions, for a total of 12ml (6ml or less than 2 teaspoons per PET scanning session). This amount of blood is easily replaced by your body.
Risks from the laboratory sleep studies (Infrequent: occur in 1-10% of participants): Some people may develop a skin irritation from the EKG or EEG electrodes, tape, paste, or other sensors worn during the sleep evaluation. This kind of skin irritation quickly resolves, 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): 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.
Risks associated with the MR procedures as other rare (occur in less than 1% of participants). 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.
Risk of psychological discomfort and symptom worsening: During the in-person assessments, some people may feel uncomfortable answering questions of a personal nature, such as questions about mood, and you may self-disclose illegal activities. You can refuse to answer any questions or questionnaires that make you uncomfortable. Symptoms you may be experiencing may become more severe during your participation in this study. If symptoms become more severe, if you have intrusive suicidal or homicidal thoughts during the study, it it is critical to you let the study coordinator and investigators know about it. If this is the case, we will discuss about the best course of action to take for immediate treatments. In oder to assure your safety during the study, it may become necessary to take steps involuntary hospitalization (commitment) or telling others about your condition and need for treatment.
Breach of confidentiality (Rare: occur in less than 1% of participants): 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.
At any time during the screening procedures, it is important that you inform the investigators of your participation in any other research prior or ongoing research studies during the past year. Your participation in our research studies that may have included medications, or procedures similar to those used in this research study (for example, PET studies, blood draws, X-Rays) and should be taken into account by the study investigators to accurately evaluate your eligibility for safe participation in this study.
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| Compensation |
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| You will be compensated based on the procedures you completed in the study. You will receive $50 for completing all screening procedures, including the sleep apnea screening night of sleep in the N-CTRC. You will then receiving $25 for completing all baseline assessments, including questionnaires and the sleep diary. Additionally, you will receive $50 for each non-screening night (nights 2 and 3) spent in the laboratory and $100 for each PET scan completed. In total, the compensation you can receive for completing all study procedures is $375. |
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