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

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea

In brief

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

Key facts

Study ID

NCT01569022

Run by

VA Office of Research and Development

People needed

42

Starts

2012-11-01

Expected to finish

2017-03-30

Last updated by the study team

2017-11-08

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Western New York Healthcare System, Buffalo, NY — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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