NCT02549508

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Fisher and Paykel Healthcare · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Obstructive Sleep Apnea (OSA)
• Post-Traumatic Stress Disorder (PTSD)

Interventions

Type	Name	Description
DEVICE	AutoCPAP with SensAwake On	The comfort feature 'SensAwake' will be turned on
DEVICE	AutoCPAP with SensAwake Off	The comfort feature 'SensAwake' will be turned off

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-03-01
• Completion: 2018-05-01
• First posted: 2015-09-15
• Last updated: 2020-11-10
• Results posted: 2020-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study