Neurobiological Correlates of Post Traumatic Stress Disorder (PTSD) During Rapid Eye Movement (REM) Sleep (REM-P)
This study has been completed.
Sponsor:
University of Pittsburgh
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00871650
First received: March 26, 2009
Last updated: January 14, 2013
Last verified: January 2013
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Purpose
The overarching aim of this Exploratory/Developmental Research Grant Award (R21) is to explore the neurobiological correlates of PTSD during REM sleep by using state-of-the science positron emission tomography (PET) sleep imaging. This study will allow us to gain insight into the differences in sleep and waking brain mechanisms between veterans with PTSD and those without PTSD.
| Condition | Intervention |
|---|---|
|
Post-Traumatic Stress Disorder |
Other: Sleep data recording Other: PET scan - waking Other: PET scan - REM Sleep |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Neurobiological Correlates of PTSD During REM Sleep (REM-P) |
Resource links provided by NLM:
Further study details as provided by University of Pittsburgh:
Primary Outcome Measures:
- Brain glucose metabolism [ Time Frame: During waking ] [ Designated as safety issue: Yes ]
- Brain glucose metabolism [ Time Frame: During REM sleep ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 24 |
| Study Start Date: | March 2009 |
| Study Completion Date: | November 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Combat Veterans with PTSD
Male Veterans of Operation Iraqi Freedom (OIF) and/or Operation Enduring Freedom (OEF), ages 18-50, with Combat Exposure Scale score > 17, who are not on medication and do not have trauma history before age 18.
|
Other: Sleep data recording
After completing the screening procedures, eligible participants will sleep in the laboratory for three consecutive nights of EEG sleep studies, one waking [18F]-FDG PET scan, and one REM sleep PET scan according to published methods.
Other: PET scan - waking
After completing the screening procedures, eligible participants will sleep in the laboratory for three consecutive nights of EEG sleep studies, one waking [18F]-FDG PET scan, and one REM sleep PET scan according to published methods.
Other: PET scan - REM Sleep
After completing the screening procedures, eligible participants will sleep in the laboratory for three consecutive nights of EEG sleep studies, one waking [18F]-FDG PET scan, and one REM sleep PET scan according to published methods.
|
|
Combat Veterans without PTSD
Male Veterans of Operation Iraqi Freedom (OIF) and/or Operation Enduring Freedom (OEF), ages 18-50, with combat experience, who are not suffering from PTSD, and who are not on medication.
|
Other: Sleep data recording
After completing the screening procedures, eligible participants will sleep in the laboratory for three consecutive nights of EEG sleep studies, one waking [18F]-FDG PET scan, and one REM sleep PET scan according to published methods.
Other: PET scan - waking
After completing the screening procedures, eligible participants will sleep in the laboratory for three consecutive nights of EEG sleep studies, one waking [18F]-FDG PET scan, and one REM sleep PET scan according to published methods.
Other: PET scan - REM Sleep
After completing the screening procedures, eligible participants will sleep in the laboratory for three consecutive nights of EEG sleep studies, one waking [18F]-FDG PET scan, and one REM sleep PET scan according to published methods.
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
Male Veterans of Operation Iraqi Freedom (OIF) and/or Operation Enduring Freedom (OEF), ages 18-50, with combat experience, who are not on medication.
Criteria
General Inclusion Criteria:
- Male OIF/OEF returnees between the ages of 18 and 45 years old
- Combat Exposure Scale score > 17
- Not taking medications known to affect sleep or wake function for at least 2 weeks (6 weeks for fluoxetine).
- No history of trauma before age 18
Specific Inclusion Criteria for Subjects with PTSD:
- Meet diagnostic criteria for current PTSD according to the CAPS-1
- CAPS-1 score is less than 80
Specific Inclusion Criteria for Subjects without PTSD:
- Total CAPS-1 scores < 17
- Does not meet criteria for PTSD
Exclusion Criteria:
- Trauma occurred less than 3 months prior to study entry
- CES score < 17
- Taking medications known to affect sleep and / or brain glucose metabolism
- Current diagnosis of depression as determined by the SCID or BDI score > 13
- History of psychotic or bipolar disorder
- Current history (within 3 months) of substance or alcohol abuse as determined by the SCID
- Positive alcohol blood test at screening or during the PET protocol
- Significant or unstable acute or chronic medical conditions
- Other current sleep disorders, such as insufficient sleep syndrome, delayed sleep phase syndrome, narcolepsy, restless legs syndrome, periodic leg movement disorder, obstructive sleep apnea, and current night shift work, suspected during the structured interview. Individuals who are found to have a apnea-hypopnea index (AHI) > 10 or an index of periodic leg movements with arousal > 15 will be excluded.
- Presence of implanted devices such as cardiac pacemaker, aneurysm clip, ear implant, shrapnel, neurostimulators or other metal devices
- Fear of closed spaces
- Previous radiation. Due to the risk of radiation exposure, we will exclude subjects who have had PET scans or other radiotracer exposure in the previous year.
- History of open head injury.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00871650 History of Changes |
| Other Study ID Numbers: | MH083035-01 |
| Study First Received: | March 26, 2009 |
| Last Updated: | January 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Pittsburgh:
|
Post Traumatic Stress Disorder PTSD Brain Imaging |
PET Neural Sleep REM Sleep |
Additional relevant MeSH terms:
|
Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Anxiety Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013