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Neurobiology of Sleep and Sleep Treatment Response in Returning Veterans (NOSSTIP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anne Germain, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01637584
First received: June 15, 2012
Last updated: April 20, 2017
Last verified: March 2017
  Purpose

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.


Condition Intervention
Non PTSD PTSD Drug: Prazosin Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Neurobiology of Sleep and Sleep Treatment Response in Returning Veterans

Resource links provided by NLM:


Further study details as provided by Anne Germain, University of Pittsburgh:

Primary Outcome Measures:
  • Whole Brain Relative Regional Cerebral Metabolic Rate of Glucose [ Time Frame: Baseline and post-intervention at 8-10 weeks ]
    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.


Secondary Outcome Measures:
  • Pittsburgh Sleep Quality Index (PSQI): [ Time Frame: Baseline and post-treatment at 8-10 weeks ]
    Self-report sleep quality measure. Scores range from 0 to 21, with higher scores reflecting poorer sleep quality.


Enrollment: 40
Study Start Date: April 2010
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Prazosin
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.
Placebo Comparator: Placebo
A placebo is a sugar pill, which will be used to compare with the results of the active medication
Drug: Placebo
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.

Detailed Description:
PTSD affects both daytime functioning and sleep. Complaints of poor sleep, objective disruption of sleep, and heightened sympathovagal tone during sleep occurring early after trauma exposure increase the risk of developing PTSD up to one year later. (1-4). Insomnia is one the most common reasons for referral to mental health services in active duty personnel (5). In military personnel returning from Iraq and Afghanistan, more than 70 percent of those with PTSD report sleep problems and fatigue, whereas more than 25% percent of those without PTSD endorse these symptoms (6). Other disruptive nocturnal behaviors and sleep disorders including sleep terrors, nocturnal anxiety attacks, simple and complex motor behaviors and vocalizations, acting out dreams, sleep apnea, and periodic leg movement disorders are also frequently reported by PTSD patients (7-12). In PTSD, sleep disturbances independently contribute to poor clinical outcomes such as increased severity of daytime PTSD symptoms (8), depression (13), suicidality (13), general psychiatric distress (14), poorer quality of life and functioning (14), poorer perceived physical health (14), and increased substance use (15;16).
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 < 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
  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: NCT01637584

Locations
United States, Pennsylvania
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anne Germain, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01637584     History of Changes
Other Study ID Numbers: PRO08050307
Study First Received: June 15, 2012
Results First Received: January 7, 2016
Last Updated: April 20, 2017

Additional relevant MeSH terms:
Prazosin
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 22, 2017