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

February 16, 2012 updated by: Mr. Shawn Gall, The VA Western New York Healthcare System
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence
Time Frame: 12 weeks
Adequate adherence will be defined as device usage of >4 hr per night for 70% of days
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The VA Western New York Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (ANTICIPATED)

March 1, 2015

Study Registration Dates

First Submitted

February 10, 2012

First Submitted That Met QC Criteria

February 16, 2012

First Posted (ESTIMATE)

February 17, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

February 17, 2012

Last Update Submitted That Met QC Criteria

February 16, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSR&D I01CX000478

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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