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Completed

NCT Number: NCT00871650

Neurobiological Correlates of Post Traumatic Stress Disorder (PTSD) During Rapid Eye Movement (REM) Sleep

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Male

Study type

Observational

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sleep data recording

Other

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.

PET scan - waking

Other

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.

PET scan - REM Sleep

Other

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.

Primary outcomes

  1. Brain glucose metabolism

    Time frame: During waking

  2. Brain glucose metabolism

    Time frame: During REM sleep

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Neurobiological Correlates of PTSD During REM Sleep (REM-P)

Acronym: REM-P

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 30, 2009
Registry last updated
Jan 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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