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

The VA Western New York Healthcare System

Status and phase: Unknown; Phase 4

Conditions: Obstructive Sleep Apnea

Treatments: Device: CPAP versus MAD

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01535586

CSR&D I01CX000478

Details and patient eligibility

About

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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

CPAP

Active Comparator group

Description:

participants will be treated with continuous positive airway pressure (CPAP) for 12 weeks

Treatment:

Device: CPAP versus MAD

MAD

Active Comparator group

Description:

Participants will be treated with a mandibular advancing device for 12 weeks

Treatment:

Device: CPAP versus MAD