A Randomized Cross Over Trial of Two Treatments for Obstructive Sleep Apnea in Veterans With Post Traumatic Stress Disorder
1 other identifier
interventional
42
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2012
CompletedFirst Posted
Study publicly available on registry
February 17, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedFebruary 17, 2012
February 1, 2012
2.9 years
February 10, 2012
February 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Adherence
12 weeks
Study Arms (2)
CPAP
ACTIVE COMPARATORparticipants will be treated with continuous positive airway pressure (CPAP) for 12 weeks
MAD
ACTIVE COMPARATORParticipants will be treated with a mandibular advancing device for 12 weeks
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- FED
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Administrative officer
Study Record Dates
First Submitted
February 10, 2012
First Posted
February 17, 2012
Study Start
April 1, 2012
Primary Completion
March 1, 2015
Last Updated
February 17, 2012
Record last verified: 2012-02