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

This study has been completed.
Sponsor:
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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871650

Locations
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
  More Information

Additional Information:
No publications provided by University of Pittsburgh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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, Traumatic
Stress Disorders, Post-Traumatic
Disease
Anxiety Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014