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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2012 by Mr. Shawn Gall, The VA Western New York Healthcare System.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Mr. Shawn Gall, The VA Western New York Healthcare System Identifier:
First received: February 10, 2012
Last updated: February 16, 2012
Last verified: February 2012
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.

Condition Intervention Phase
Obstructive Sleep Apnea
Device: CPAP versus MAD
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Mr. Shawn Gall, The VA Western New York Healthcare System:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 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:
  • Adherence [ Time Frame: 12 weeks ]
    Adequate adherence will be defined as device usage of >4 hr per night for 70% of days

Estimated Enrollment: 42
Study Start Date: April 2012
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CPAP
participants will be treated with continuous positive airway pressure (CPAP) for 12 weeks
Device: CPAP versus MAD
Cross over design
Active Comparator: MAD
Participants will be treated with a mandibular advancing device for 12 weeks
Device: CPAP versus MAD
Cross over design


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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No Contacts or Locations Provided
  More Information

Responsible Party: Mr. Shawn Gall, Administrative officer, The VA Western New York Healthcare System Identifier: NCT01535586     History of Changes
Other Study ID Numbers: CSR&D I01CX000478
Study First Received: February 10, 2012
Last Updated: February 16, 2012

Keywords provided by Mr. Shawn Gall, The VA Western New York Healthcare System:
sleep apnea

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases processed this record on May 25, 2017