Clinical trial NCT02549508: Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD
Official title: Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea (OSA)
Post-Traumatic Stress Disorder (PTSD)
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2015-09-15
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Adherence (Hours on Therapy)
timeFrame: 4 weeks
Secondary outcomes:
measure: Sleep Quality (Epworth Sleepiness Scale (ESS)
timeFrame: Change from Baseline after 4 weeks
measure: Insomnia Severity Index (ISI)
timeFrame: Change from Baseline after 4 weeks
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Walter Reed National Military Medical Center
name: Aaron B Holley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fisher & Paykel Healthcare
name: Rebecca Thomson, MA
role: STUDY_CHAIR
References:
citation: Holley A, Shaha D, Costan-Toth C, Slowik J, Robertson BD, Williams SG, Terry S, Golden D, Andrada T, Skeete S, Sheikh K, Butler G, Collen JF. A randomized, placebo-controlled trial using a novel PAP delivery platform to treat patients with OSA and comorbid PTSD. Sleep Breath. 2020 Sep;24(3):1001-1009. doi: 10.1007/s11325-019-01936-x. Epub 2019 Nov 6.