- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01637584
Neurobiology of Sleep and Sleep Treatment Response in Returning Veterans (NOSSTIP)
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Western Psychiatric Institute and Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 < 13 on the Beck Depression Inventory
- Participants who are active-duty military personnel will be required to obtain permission from their commander to participate in this study.
Exclusion Criteria:
- Current diagnosis of untreated, severe depression as determined by the Structured Clinical Interview for Diagnostic and Statistical Manual- IV Edition (DSM-IV), non-patient version
- Beck Depression Inventory > 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 < 90/60 at the screening physical examination
- Heart rate > 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Prazosin
Active medication arm.
Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication.
Side effects of the medication in some include sleepiness and once asleep, sustained sleep.
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The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking.
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Placebo Comparator: Placebo
A placebo is a sugar pill, which will be used to compare with the results of the active medication
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The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whole Brain Relative Regional Cerebral Metabolic Rate of Glucose
Time Frame: Baseline and post-intervention at 8-10 weeks
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The reported Z value reflect the magnitude of the state difference (Wake vs. Non-REM or Wake vs. REM) within the prazosin group pre-to-post treatment, and after using a mask to adjust for the spurious effects of the passage of time.
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Baseline and post-intervention at 8-10 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pittsburgh Sleep Quality Index (PSQI):
Time Frame: Baseline and post-treatment at 8-10 weeks
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Self-report sleep quality measure.
Scores range from 0 to 21, with higher scores reflecting poorer sleep quality.
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Baseline and post-treatment at 8-10 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PRO08050307
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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