N/A Completed N=85 Randomized Single-blind Treatment

Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD

Obstructive Sleep Apnea (OSA) · Post-Traumatic Stress Disorder

Source: ClinicalTrials.gov NCT02549508 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2020

Primary outcomePrimary: Adherence (Hours on Therapy) — 1.1; 0.5 Hours/night

Summary

The purpose of this research is to examine the application of AutoCPAP with and without SensAwake in subjects with OSA and Post-Traumatic Stress Disorder (PTSD), and evaluate whether patients achieve better sleep quality and compliance with SensAwake, compared to the same treatment without SensAwake.

Outcome Measures

Outcome	Result	p-value
PRIMARY Adherence (Hours on Therapy)	1.1; 0.5	—
SECONDARY Sleep Quality (Epworth Sleepiness Scale (ESS)	-2.4; -3.0	—
SECONDARY Insomnia Severity Index (ISI)	-4.2; -4.4	—

Eligibility Criteria

Inclusion Criteria

Male and female subjects > 18 years Diagnosed with OSA by a practicing sleep physician, within the last six months Diagnosed with post-traumatic stress disorder as diagnosed by a behavioral health professional, and quantified by McChord PTSD checklist All races and ethnicities will be included Naïve to CPAP therapy (has not used CPAP within the last 5 years)

Exclusion Criteria

< 18 years of age if mental status is questionable, the patient will be excluded at the discretion of the consenting provider Unable/unwilling to follow the directions necessary for CPAP use Patients contraindicated for CPAP/AutoCPAP, at the discretion of the consenting provider

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02549508). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.