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

Obstructive Sleep Apnea Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01535586
• Other study ID #: CSR&D I01CX000478
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 10, 2012
• Last updated: February 16, 2012
• Start date: April 2012

Study information

• Verified date: February 2012
• Source: The VA Western New York Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Stress Disorders, Post-Traumatic

Intervention

Device:
• CPAP versus MAD
Cross over design

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The VA Western New York Healthcare System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adherence	Adequate adherence will be defined as device usage of >4 hr per night for 70% of days	12 weeks	No