Neurobiology of Sleep and Sleep Treatment Response in Returning Veterans
Condition: Non PTSD; PTSD
Study type: Interventional

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.
    

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).
    

Intervention name(s): Prazosin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Intervention MeSH terms: Prazosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment