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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02549508
Other study ID # CIA 134
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2015
Est. completion date May 2018

Study information

Verified date October 2020
Source Fisher and Paykel Healthcare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 85
Est. completion date May 2018
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
AutoCPAP with SensAwake On
The comfort feature 'SensAwake' will be turned on
AutoCPAP with SensAwake Off
The comfort feature 'SensAwake' will be turned off

Locations

Country Name City State
United States Walter Reed National Military Medical Center Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adherence (Hours on Therapy) Hours per night averaged over total time period measured. 4 weeks
Secondary Sleep Quality (Epworth Sleepiness Scale (ESS) The ESS is a validated questionnaire that assesses an idnviduals likelihood of falling asleep in a variety of given situations (such as having a conversation with someone or stopped a red light while driving.) Each question is given a rating between 0 and 3, with 0 being no chance of falling asleep and 3 being high chance of falling asleep. Answers are then summed together to determine the level of sleepiness an individual is experiencing with a maximum score of 24. The higher the score, the more sleepy the person is. From a clinical perspective an ESS score of 0-10 indicates a normal level sleepiness, a score of 11-14 indicates mild sleepiness, a score of 15-17 indicates moderate sleepiness and a score of 18+ indicates severe sleepiness. Results below are reported as a mean change from baseline in which negative scores indicate reduction in ESS from baseline (less sleepiness). Positive scores indicate increase in ESS from baseline (more sleepiness.) Change from Baseline after 4 weeks
Secondary Insomnia Severity Index (ISI) ISI; 0-7 = No clinically significant insomnia, 8-14 = Sub threshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe). Results reported in mean change from baseline. Negative scores indicate improvement in ISI, positive scores indicate increase in ISI. Change from Baseline after 4 weeks
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