Neurobiology of Sleep and Sleep Treatment Response in Returning Veterans

PTSD Clinical Trial

— NOSSTIP  

Official title:

Neurobiology of Sleep and Sleep Treatment Response in Returning Veterans

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01637584
• Other study ID #: PRO08050307
• Status: Active, not recruiting
• Phase: N/A
• First received: June 15, 2012
• Last updated: July 13, 2012
• Start date: April 2010
• Est. completion date: November 2012

Study information

• Verified date: July 2012
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The overarching objectives of this study are: 1) To investigate the neurobiology of posttraumatic stress disorder (PTSD) during REM and 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 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 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, mPFC, and brain centers involved in the regulation of NREM and REM sleep, and that these neurobiological changes are normalized with effective sleep treatment.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 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 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Non PTSD
• PTSD

Intervention

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
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.

Locations

Country	Name	City	State
United States	Western Psychiatric Institute and Clinic	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	Neuroimaging data from Positron Emission Tomography	Conducted prior to intervention and following intervention as a means of reporting change.	Pre intervention and 8-10 weeks later	No