A Randomized Cross Over Trial of Two Treatments for Obstructive Sleep Apnea in Veterans With Post Traumatic Stress Disorder

Phase 4

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: CPAP versus MAD

• Registration Number: NCT01535586
• Lead Sponsor: The VA Western New York Healthcare System

Brief 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 mandibular advancing devices-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 MAD response.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-02
• Study First Submitted: 2012-02-10
• Study First Submitted QC: 2012-02-16
• Last Update Submitted: 2012-02-16
• Study First Posted: 2012-02-17
• Last Update Posted: 2012-02-17
• Study Start: 2012-04
• Primary Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• • Consecutive patients aged 18-70 years of age

  • Documented obstructive sleep apnea by polysomnography (AHI≥5 or more/hr)
  • Established diagnosis of PTSD related to any past lifetime traumatic event and have a diagnosis of current, chronic PTSD

Exclusion Criteria

• • Central sleep apnea defined as central apnea/hypopnea >50% of the total respiratory events

  • Prior treatment for sleep apnea
  • Veterans with fewer than 4 teeth remaining in either arch
  • Coexisting narcolepsy
  • Tempo-mandibular joint disease
  • Epilepsy
  • Prominent suicidal or homicidal ideation
  • Diagnosis of dementia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CPAP	CPAP versus MAD	participants will be treated with continuous positive airway pressure (CPAP) for 12 weeks
MAD	CPAP versus MAD	Participants will be treated with a mandibular advancing device for 12 weeks

Primary Outcome Measures

Name	Time	Method
Efficacy	12 weeks	The primary objective of this trial is to assess the efficacy of MAD versus CPAP in the treatment of OSA in Veterans with PTSD.Treatment will be considered efficacious (successful) when the apnea-hypopnea index is \< 5 in the absence of hypoxemia defined as SvO2\<90%.

Secondary Outcome Measures

Name	Time	Method
Adherence	12 weeks	Adequate adherence will be defined as device usage of \>4 hr per night for 70% of days