Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD
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|ClinicalTrials.gov Identifier: NCT02549508|
Recruitment Status : Completed
First Posted : September 15, 2015
Last Update Posted : August 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea (OSA) Post-Traumatic Stress Disorder (PTSD)||Device: AutoCPAP with SensAwake On Device: AutoCPAP with SensAwake Off||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||87 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD|
|Actual Study Start Date :||October 2015|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||May 2018|
Experimental: AutoCPAP with SensAwake On
The comfort feature 'SensAwake' will be turned on whilst participants continue to receive PAP therapy
Device: AutoCPAP with SensAwake On
The comfort feature 'SensAwake' will be turned on
Active Comparator: AutoCPAP with SensAwake Off
The comfort feature 'SensAwake' will be turned off whilst participants continue to receive PAP therapy
Device: AutoCPAP with SensAwake Off
The comfort feature 'SensAwake' will be turned off
- Adherence (Hours on therapy) [ Time Frame: 4 weeks ]Hours per night averaged over total time period measured.
- Sleep Quality (Epworth Sleepiness Scale (ESS) [ Time Frame: 8 hours ]ESS; 0-9 Normal, 11-15 Mild, 16+ Possibility of Severe Sleep Apnea.
- Insomnia Severity Index (ISI) [ Time Frame: 8 hours ]ISI; 0-7 = No clinically significant insomnia, 8-14 = Sub threshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe).
- Sleep Diary completion [ Time Frame: 8 hours ]subjective sleep quality
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549508
|United States, Maryland|
|Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20889|
|Principal Investigator:||Aaron B Holley, MD||Walter Reed National Military Medical Center|
|Study Chair:||Rebecca Thomson, MA||Fisher & Paykel Healthcare|