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

Recruiting in Palo Alto (17 mi)

Overseen by Ali A El-Solh, MD MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

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

Participant Groups

Group I: MAD First, CPAP Experimental Treatment 2 Interventions

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

Group II: CPAP First, MAD Active Control 2 Interventions

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

VA Western New York Healthcare System, Buffalo, NY Buffalo, NY

Who Is Running the Clinical Trial?

VA Office of Research and Development Lead Sponsor

References