N/A
N=40
Neurobiology of Sleep and Sleep Treatment Response in Returning Veterans
Non PTSD · PTSD
Bottom Line
View on ClinicalTrials.gov: NCT01637584 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Whole Brain Relative Regional Cerebral Metabolic Rate of Glucose — 3.78; 3.76; 3.52; 3.36 Z values — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prazosin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Whole Brain Relative Regional Cerebral Metabolic Rate of Glucose |
3.78; 3.76; 3.52; 3.36; 4.12; 3.89 | <0.001 sig |
| SECONDARY Pittsburgh Sleep Quality Index (PSQI): |
9.25; 8.08; 6.71; 6.54 | — |
Summary
The overarching objectives of this study are: 1) To investigate the neurobiology of posttraumatic stress disorder (PTSD) during Rapid Eye Movement (REM) and Non-Rapid Eye Movement (NREM) sleep relative to wakefulness; 2) To identify the neurobiological underpinnings of sleep treatment response to prazosin or placebo during wakefulness, REM sleep, and NREM sleep in Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) ( veterans with PTSD; and 3) To explore pre-treatment brain activity patterns during wakefulness, REM sleep, and NREM sleep that predict sleep treatment response. We will also explore the stability of the Positron Emission Tomography (PET) signal by comparing pre- and post-placebo changes in brain glucose metabolism in non-responders. For non-PTSD veterans, the stability of the PET signal will be evaluated in a subsample of 6 veterans without PTSD who will repeat the PET imaging procedures 8 weeks after the initial PET series.
The overarching hypothesis is that PTSD is characterized by neurobiological alterations in the amygdala, medial prefrontal cortex (mPFC), and brain centers involved in the regulation of NREM and REM sleep, and that these neurobiological changes are normalized with effective sleep treatment.
Eligibility Criteria
Inclusion Criteria
- OIF/OEF veteran
- Between the ages of 18 and 50 years old
- Not taking medications known to affect sleep or wake function for 2 weeks
Additional selection criteria for PTSD subjects are:
- Trauma occurred three months or more before study entry
- Meeting diagnostic criteria for current PTSD according to the Clinician Administered PTSD Scale (CAPS)
- Participants will remain in ongoing counseling services
Additional selection criterion for non-PTSD healthy subjects:
- Not meet DSM-IV diagnostic criteria for current PTSD
- Have a total score 30
- History of psychotic or bipolar disorder
- Current history (within 3 months) of substance or alcohol abuse
- Significant or unstable acute or chronic medical conditions
- Other current sleep disorders
- Presence of implanted devices or metal in body such as cardiac pacemaker, aneurysm clip, ear implant, shrapnel, neurostimulators or other metal devices
- Fear of closed spaces
- Previous radiation exposure (past year) that exceeds recommended safety limits
- Pregnancy or breast feeding
- Resting blood pressure 100 beats/minutes
- Current use of a beta-blocker
- Use of an alpha-1 antagonist agent in the previous 3 weeks
- Refusal to follow the safety measures in the case of use of a phosphodiesterase 5 inhibitor (Cialis, Viagra, Levitra)
- Unexpected, untreated, or serious EKG findings
Data sourced from ClinicalTrials.gov (NCT01637584). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.