Sleep data recording and PET scan - waking and PET scan - REM Sleep in Post-Traumatic Stress Disorder - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Post-Traumatic Stress Disorder

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

24

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15213
    - University of Pittsburgh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Control
Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

Group / Cohort

Intervention / Treatment

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