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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01535586
Recruitment Status : Unknown
Verified February 2012 by Mr. Shawn Gall, The VA Western New York Healthcare System.
Recruitment status was:  Not yet recruiting
First Posted : February 17, 2012
Last Update Posted : February 17, 2012
Information provided by (Responsible Party):
Mr. Shawn Gall, 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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: CPAP versus MAD Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2012
Estimated Primary Completion Date : March 2015

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 :
  1. Adherence [ Time Frame: 12 weeks ]
    Adequate adherence will be defined as device usage of >4 hr per night for 70% of days

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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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Responsible Party: Mr. Shawn Gall, Administrative officer, The VA Western New York Healthcare System Identifier: NCT01535586    
Other Study ID Numbers: CSR&D I01CX000478
First Posted: February 17, 2012    Key Record Dates
Last Update Posted: February 17, 2012
Last Verified: February 2012
Keywords provided by Mr. Shawn Gall, The VA Western New York Healthcare System:
sleep apnea
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases