Clinical trial NCT00871650: Neurobiological Correlates of Post Traumatic Stress Disorder (PTSD) During Rapid Eye Movement (REM) Sleep
Official title: Neurobiological Correlates of PTSD During REM Sleep (REM-P)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-Traumatic Stress Disorder
Keywords: Post Traumatic Stress Disorder
PTSD
Brain
Imaging
PET
Neural
Sleep
REM Sleep
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2009-03-30
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Brain glucose metabolism
timeFrame: During waking
measure: Brain glucose metabolism
timeFrame: During REM sleep
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References:
citation: Stocker RP, Cieply MA, Paul B, Khan H, Henry L, Kontos AP, Germain A. Combat-related blast exposure and traumatic brain injury influence brain glucose metabolism during REM sleep in military veterans. Neuroimage. 2014 Oct 1;99:207-14. doi: 10.1016/j.neuroimage.2014.05.067. Epub 2014 Jun 2.