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

Post-Traumatic Stress Disorder Clinical Trial

— REM-P  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871650
• Other study ID #: MH083035-01
• Status: Completed
• Phase: N/A
• First received: March 26, 2009
• Last updated: January 14, 2013
• Start date: March 2009
• Est. completion date: November 2011

Study information

• Verified date: January 2013
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain glucose metabolism		During waking	Yes
Primary	Brain glucose metabolism		During REM sleep	No

External Links

•   Website of University of Pittsburgh sleep research studies for military veterans.