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

NCT ID: NCT01535586

Last Updated: 2012-02-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30

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 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

Obstructive Sleep Apnea

Study Design

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

Study Groups

CPAP

participants will be treated with continuous positive airway pressure (CPAP) for 12 weeks

Group Type: ACTIVE_COMPARATOR

CPAP versus MAD

Intervention Type: DEVICE

Cross over design

MAD

Participants will be treated with a mandibular advancing device for 12 weeks

Group Type: ACTIVE_COMPARATOR

CPAP versus MAD

Intervention Type: DEVICE

Cross over design

Interventions

CPAP versus MAD

Cross over design

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
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The VA Western New York Healthcare System

FED

Sponsor Role: lead

Responsible Party

Mr. Shawn Gall

Administrative officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CSR&D I01CX000478

Identifier Type: -

Identifier Source: org_study_id