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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01569022
First received: March 20, 2012
Last updated: June 11, 2014
Last verified: June 2014
  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 oral appliances-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 oral appliance response


Condition Intervention
Obstructive Sleep Apnea
Device: CPAP
Device: MAD

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Cross Over Trial of Two Treatments for OSA in Veterans With PTSD

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Efficacy of continuous positive airway pressure versus mandibular advancing device in treating sleep apnea [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    comparison of apnea-hypopnea index (/hr) at end of 12 weeks period between CPAP and MAD


Secondary Outcome Measures:
  • Quality of life assessed through a standard questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    comparison of the composite score of the SF36 questionnaire between CPAP and MAD at 12 weeks period

  • Adherence to therapy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    comparison of the number of days used while on CPAP versus MAD


Estimated Enrollment: 42
Study Start Date: November 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
CPAP treatment for sleep apnea
Device: CPAP
CPAP Treatment for 12 weeks
Experimental: Arm 2
MAD treatment for sleep apnea
Device: MAD
MAD Treatment for 12 weeks

Detailed Description:

Obstructive sleep apnea (OSA) is a prevalent disorder associated with poor neurocognitive performance and organ system dysfunction due to intermittent hypoxia and repeated arousals. The repetitive hemodynamic stresses are implicated in the increased incidence of systemic hypertension and cardiovascular diseases. Insufficient and disrupted sleep has similar negative impact on mood, attention, cognition, and behavior. In Veterans with post traumatic stress disorder (PTSD), the disturbed sleep can worsen further the cognitive-behavioral manifestations of PTSD and contributes to poor mental and physical health outcomes. Recent epidemiologic studies largely support the association of higher rates of OSA in patients with PTSD compared with the general population. Treatment of the underlying obstructive sleep disturbances with continuous positive airway pressure (CPAP) has resulted in restoration of sleep architecture, decrease daytime sleepiness, and reduction in nightmares frequency and intensity. However, adherence to treatment with CPAP is less than optimal in Veterans with PTSD. Mandibular advancing devices (MADs) are considered non surgical alternatives to CPAP and are preferred in a head to head comparison to CPAP in OSA subjects without PTSD. However, there has been no study to our knowledge that has assessed MAD in terms of clinical efficacy, compliance, and quality of sleep compared to CPAP in OSA patients with PTSD. Therefore, we hypothesize that MAD is not inferior to CPAP in treating OSA effectively in Veterans with PTSD and OSA. To that end, we propose to conduct a feasibility study using a randomized crossover trial of 12 weeks of CPAP and MAD in 42 consecutive outpatients with PTSD newly diagnosed with OSA separated by 2 weeks washout period.

The primary endpoint of the trial is to compare the treatment efficacy of CPAP and MAD in Veterans with PTSD and OSA. Secondary endpoints aim at: 1) comparing change in the Epworth Sleepiness Scale, SF-36, and the Pittsburgh Sleep Quality Index at end of treatment following use of CPAP versus MAD, 2) comparing adherence and short-term side effects between using CPAP and MAD in PTSD patients with OSA, and 3) determining anthropomorphic, polysomnographic, and cephalometric predictors of successful MDA response. Assessments at the end of both limbs comprise evaluation of quality of sleep, daytime sleepiness, quality of life, and side effects of treatment. Compliance with each therapy will be measured at the end of each treatment period.

The results of the trial are pivotal in determining the efficacy, tolerability, and adherence to MAD compared to CPAP in Veterans with PTSD and OSA. This feasibility study would form the basis of a future trial examining the effectiveness of various therapeutic modalities for OSA on PTSD symptomatology and progression.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569022

Contacts
Contact: Ali A El-Solh, MD MPH (716) 862-6528 ali.el-solh@va.gov
Contact: Kerry T Donnelly, PhD (716) 862-8597 Kerry.Donnelly@va.gov

Locations
United States, New York
VA Western New York Healthcare System, Buffalo, NY Recruiting
Buffalo, New York, United States, 14215
Contact: Ali A El-Solh, MD MPH    716-862-6528    ali.el-solh@va.gov   
Principal Investigator: Ali A El-Solh, MD MPH         
Sponsors and Collaborators
Investigators
Principal Investigator: Ali A El-Solh, MD MPH VA Western New York Healthcare System, Buffalo, NY
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01569022     History of Changes
Other Study ID Numbers: CLIN-005-11F
Study First Received: March 20, 2012
Last Updated: June 11, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
post traumatic stress disorder
continuous positive airway pressure
oral appliance

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

ClinicalTrials.gov processed this record on October 19, 2014