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

Study Overview
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Brief Summary
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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.

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: CPAP versus MAD


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CPAP<br>participants will be treated with continuous positive airway pressure (CPAP) for 12 weeks | Device: CPAP versus MAD<br>* Cross over design<br>|
| Active Comparator: MAD<br>Participants will be treated with a mandibular advancing device for 12 weeks | Device: CPAP versus MAD<br>* Cross over design<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | 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%. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence | Adequate adherence will be defined as device usage of >4 hr per night for 70% of days | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPAP, MAD, sleep apnea, PTSD