CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 42 enrolled
Drug / intervention
CPAP +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01569022
NCT01569022N/ACompleted
CompareCT.gov

A Randomized Cross Over Trial of Two Treatments for OSA in Veterans With PTSD

VA Office of Research and Development·interventional·Posted Apr 2, 2012·Updated Nov 8, 2017

In Brief

A clinical study evaluating CPAP and MAD for Obstructive Sleep Apnea. Completed, enrolled 42 participants across 1 site.

Detailed 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 oral appliances-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 oral appliance response

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedApr 2, 2012
Enrollment StartNov 1, 2012
Primary CompletionOct 30, 2016
Study CompletionMar 30, 2017
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 14.3 years ago

Interventions

CPAPdevice

CPAP Treatment for 12 weeks

MADdevice

MAD Treatment for 12 weeks