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

Primary Purpose

Obstructive Sleep Apnea

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
CPAP versus MAD
Sponsored by
The VA Western New York Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring CPAP, MAD, sleep apnea, PTSD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    CPAP

    MAD

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Efficacy
    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
    Adequate adherence will be defined as device usage of >4 hr per night for 70% of days

    Full Information

    First Posted
    February 10, 2012
    Last Updated
    February 16, 2012
    Sponsor
    The VA Western New York Healthcare System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01535586
    Brief Title
    A Randomized Cross Over Trial of Two Treatments for Obstructive Sleep Apnea in Veterans With Post Traumatic Stress Disorder
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    March 2015 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    The VA Western New York Healthcare System

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstructive Sleep Apnea
    Keywords
    CPAP, MAD, sleep apnea, PTSD

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    42 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CPAP
    Arm Type
    Active Comparator
    Arm Description
    participants will be treated with continuous positive airway pressure (CPAP) for 12 weeks
    Arm Title
    MAD
    Arm Type
    Active Comparator
    Arm Description
    Participants will be treated with a mandibular advancing device for 12 weeks
    Intervention Type
    Device
    Intervention Name(s)
    CPAP versus MAD
    Intervention Description
    Cross over design
    Primary Outcome Measure Information:
    Title
    Efficacy
    Description
    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%.
    Time Frame
    12 weeks
    Secondary Outcome Measure Information:
    Title
    Adherence
    Description
    Adequate adherence will be defined as device usage of >4 hr per night for 70% of days
    Time Frame
    12 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

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