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



Status:Completed
Conditions:Insomnia Sleep Studies, Psychiatric, Psychiatric, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:8/5/2018
Start Date:October 2015
End Date:May 2018

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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.

Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the
pressure during wakefulness may improve therapy comfort and potentially adherence without
compromising therapy efficacy. SensAwake™ is a unique pressure relief technology developed by
Fisher & Paykel Healthcare which detects irregularity in the flow signal indicative of the
transition from sleep to wake. When the transition from sleep to wake is detected the device
promptly reduces the pressure to help facilitate a return to sleep.

It is hypothesised that AutoCPAP with SensAwake will improve patient comfort and compliance
in the PTSD and OSA patients who are naïve to CPAP therapy.

The investigators will not be blinded to the study. The participants will be blinded to the
study.

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
We found this trial at
1
site
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Phone: 301-400-1406
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
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mi
from
Bethesda, MD
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