A Randomized Cross Over Trial of Two Treatments for Obstructive Sleep Apnea in Veterans With Post Traumatic Stress Disorder
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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 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Obstructive Sleep Apnea |
Device: CPAP versus MAD |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
- Efficacy [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]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%.
- Adherence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]Adequate adherence will be defined as device usage of >4 hr per night for 70% of days
| Estimated Enrollment: | 42 |
| Study Start Date: | April 2012 |
| Estimated Primary Completion Date: | March 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: CPAP
participants will be treated with continuous positive airway pressure (CPAP) for 12 weeks
|
Device: CPAP versus MAD
Cross over design
|
|
Active Comparator: MAD
Participants will be treated with a mandibular advancing device for 12 weeks
|
Device: CPAP versus MAD
Cross over design
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 More Information
No publications provided
| Responsible Party: | Mr. Shawn Gall, Administrative officer, The VA Western New York Healthcare System |
| ClinicalTrials.gov Identifier: | NCT01535586 History of Changes |
| Other Study ID Numbers: | CSR&D I01CX000478 |
| Study First Received: | February 10, 2012 |
| Last Updated: | February 16, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by The VA Western New York Healthcare System:
|
CPAP MAD sleep apnea PTSD |
Additional relevant MeSH terms:
|
Apnea Sleep Apnea Syndromes Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Sleep Apnea, Obstructive 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 May 21, 2013