A Randomized Cross Over Trial of Two Treatments for Sleep Apnea in Veterans With Post-Traumatic Stress Disorder
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Sleep disturbances are cardinal features of Veterans with post traumatic stress disorder
      (PTSD). In particular, obstructive sleep apnea is reported to occur more frequently in
      patients with PTSD compared to those without PTSD and contribute to worsening cognitive and
      behavioral functions. Continuous positive airway pressure (CPAP) is considered the treatment
      of choice for OSA but adherence to CPAP in Veterans with PTSD is poor compared to the general
      population. The proposed study aims at comparing the efficacy, tolerability, and adherence of
      oral appliances-an alternative therapy to OSA- to CPAP. The study is instrumental in
      identifying the optimal OSA therapy for Veterans with PTSD and the OSA phenotype that would
      predict oral appliance response
    

Detailed description: 
      Obstructive sleep apnea (OSA) is a prevalent disorder associated with poor neurocognitive
      performance and organ system dysfunction due to intermittent hypoxia and repeated arousals.
      The repetitive hemodynamic stresses are implicated in the increased incidence of systemic
      hypertension and cardiovascular diseases. Insufficient and disrupted sleep has similar
      negative impact on mood, attention, cognition, and behavior. In Veterans with post traumatic
      stress disorder (PTSD), the disturbed sleep can worsen further the cognitive-behavioral
      manifestations of PTSD and contributes to poor mental and physical health outcomes. Recent
      epidemiologic studies largely support the association of higher rates of OSA in patients with
      PTSD compared with the general population. Treatment of the underlying obstructive sleep
      disturbances with continuous positive airway pressure (CPAP) has resulted in restoration of
      sleep architecture, decrease daytime sleepiness, and reduction in nightmares frequency and
      intensity. However, adherence to treatment with CPAP is less than optimal in Veterans with
      PTSD. Mandibular advancing devices (MADs) are considered non surgical alternatives to CPAP
      and are preferred in a head to head comparison to CPAP in OSA subjects without PTSD. However,
      there has been no study to the investigators' knowledge that has assessed MAD in terms of
      clinical efficacy, compliance, and quality of sleep compared to CPAP in OSA patients with
      PTSD. Therefore, the investigators hypothesize that MAD is not inferior to CPAP in treating
      OSA effectively in Veterans with PTSD and OSA. To that end, the investigators propose to
      conduct a feasibility study using a randomized crossover trial of 12 weeks of CPAP and MAD in
      42 consecutive outpatients with PTSD newly diagnosed with OSA separated by 2 weeks washout
      period.

      The primary endpoint of the trial is to compare the treatment efficacy of CPAP and MAD in
      Veterans with PTSD and OSA. Secondary endpoints aim at: 1) comparing change in the Epworth
      Sleepiness Scale, SF-36, and the Pittsburgh Sleep Quality Index at end of treatment following
      use of CPAP versus MAD, 2) comparing adherence and short-term side effects between using CPAP
      and MAD in PTSD patients with OSA, and 3) determining anthropomorphic, polysomnographic, and
      cephalometric predictors of successful MDA response. Assessments at the end of both limbs
      comprise evaluation of quality of sleep, daytime sleepiness, quality of life, and side
      effects of treatment. Compliance with each therapy will be measured at the end of each
      treatment period.

      The results of the trial are pivotal in determining the efficacy, tolerability, and adherence
      to MAD compared to CPAP in Veterans with PTSD and OSA. This feasibility study would form the
      basis of a future trial examining the effectiveness of various therapeutic modalities for OSA
      on PTSD symptomatology and progression.
    

Intervention name(s): CPAP; MAD
Intervention type(s): Device; Device
Intervention description(s): CPAP Treatment for 12 weeks; MAD Treatment for 12 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: post traumatic stress disorder; continuous positive airway pressure; oral appliance