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

Fisher & Paykel Healthcare

Status: Completed

Conditions: Post-Traumatic Stress Disorder (PTSD); Obstructive Sleep Apnea (OSA)

Treatments: Device: AutoCPAP with SensAwake Off; Device: AutoCPAP with SensAwake On

Study type: Interventional

Funder types: Industry

Identifiers

NCT02549508

CIA 134

Details and patient eligibility

About

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.

Full 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.

Enrollment: 85 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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85 participants in 2 patient groups

AutoCPAP with SensAwake On, then SenAwake Off

Experimental group

Description:

Participants will start AutoCPAP treatment with SensAwake on for 4 weeks. After 4 weeks, the will cross over to SensAwake off for another 4 weeks.

Treatment:

Device: AutoCPAP with SensAwake On

Device: AutoCPAP with SensAwake Off

AutoCPAP with SensAwake Off, then SensAwake On

Experimental group

Description:

Participants will start AutoCPAP treatment with SensAwake Off for 4 weeks. After 4 weeks, the will cross over to SensAwake On for another 4 weeks.

Treatment:

Device: AutoCPAP with SensAwake On

Device: AutoCPAP with SensAwake Off