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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2012 by The VA Western New York Healthcare System
Sponsor:
Information provided by (Responsible Party):
Mr. Shawn Gall, The VA Western New York Healthcare System
ClinicalTrials.gov Identifier:
NCT01535586
First received: February 10, 2012
Last updated: February 16, 2012
Last verified: February 2012
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by The VA Western New York Healthcare System:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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

Keywords provided by The VA Western New York Healthcare System:
CPAP
MAD
sleep apnea
PTSD

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Sleep Disorders, Intrinsic
Sleep Disorders
Stress Disorders, Post-Traumatic
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Nervous System Diseases
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014