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

NCT ID: NCT01569022

Last Updated: 2017-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-01
• Study Completion Date: 2017-03-30

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 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

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 the investigators' knowledge that has assessed MAD in terms of clinical efficacy, compliance, and quality of sleep compared to CPAP in OSA patients with PTSD. Therefore, the investigators hypothesize that MAD is not inferior to CPAP in treating OSA effectively in Veterans with PTSD and OSA. To that end, the investigators 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.

Conditions

Obstructive Sleep Apnea

Keywords

post traumatic stress disorder; continuous positive airway pressure; oral appliance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CPAP First, MAD

CPAP treatment for sleep apnea

CPAP: CPAP Treatment for 12 weeks MAD: MAD treatment for 12 weeks

Group Type: ACTIVE_COMPARATOR

CPAP

Intervention Type: DEVICE

CPAP Treatment for 12 weeks

MAD

Intervention Type: DEVICE

MAD Treatment for 12 weeks

MAD First, CPAP

MAD treatment for sleep apnea

MAD: MAD Treatment for 12 weeks CPAP: CPAP treatment for 12 weeks

Group Type: EXPERIMENTAL

CPAP

Intervention Type: DEVICE

CPAP Treatment for 12 weeks

MAD

Intervention Type: DEVICE

MAD Treatment for 12 weeks

Interventions

CPAP

CPAP Treatment for 12 weeks

Intervention Type: DEVICE

MAD

MAD Treatment for 12 weeks

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ali A El-Solh, MD MPH

Role: PRINCIPAL_INVESTIGATOR

VA Western New York Healthcare System, Buffalo, NY

Locations

VA Western New York Healthcare System, Buffalo, NY

Buffalo, New York, United States

Countries

United States

References

El-Solh AA, Homish GG, Ditursi G, Lazarus J, Rao N, Adamo D, Kufel T. A Randomized Crossover Trial Evaluating Continuous Positive Airway Pressure Versus Mandibular Advancement Device on Health Outcomes in Veterans With Posttraumatic Stress Disorder. J Clin Sleep Med. 2017 Nov 15;13(11):1327-1335. doi: 10.5664/jcsm.6808.

Reference Type: DERIVED

PMID: 29065960 (View on PubMed)

Other Identifiers

CLIN-005-11F

Identifier Type: -

Identifier Source: org_study_id