Back to resultsComparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD
Primary Purpose
Obstructive Sleep Apnea (OSA), Post-Traumatic Stress Disorder (PTSD)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AutoCPAP with SensAwake On
AutoCPAP with SensAwake Off
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea (OSA)
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
Sites / Locations
- Walter Reed National Military Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
AutoCPAP with SensAwake On, then SenAwake Off
AutoCPAP with SensAwake Off, then SensAwake On
Arm 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.
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.
Outcomes
Primary Outcome Measures
Adherence (Hours on Therapy)
Hours per night averaged over total time period measured.
Secondary Outcome Measures
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.)
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.
Full Information
NCT ID
NCT02549508
First Posted
September 9, 2015
Last Updated
October 19, 2020
Sponsor
Fisher and Paykel Healthcare
1. Study Identification
Unique Protocol Identification Number
NCT02549508
Brief Title
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
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 2015 (Actual)
Primary Completion Date
March 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea (OSA), Post-Traumatic Stress Disorder (PTSD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AutoCPAP with SensAwake On, then SenAwake Off
Arm Type
Experimental
Arm 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.
Arm Title
AutoCPAP with SensAwake Off, then SensAwake On
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
AutoCPAP with SensAwake On
Intervention Description
The comfort feature 'SensAwake' will be turned on
Intervention Type
Device
Intervention Name(s)
AutoCPAP with SensAwake Off
Intervention Description
The comfort feature 'SensAwake' will be turned off
Primary Outcome Measure Information:
Title
Adherence (Hours on Therapy)
Description
Hours per night averaged over total time period measured.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Sleep Quality (Epworth Sleepiness Scale (ESS)
Description
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.)
Time Frame
Change from Baseline after 4 weeks
Title
Insomnia Severity Index (ISI)
Description
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.
Time Frame
Change from Baseline after 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron B Holley, MD
Organizational Affiliation
Walter Reed National Military Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rebecca Thomson, MA
Organizational Affiliation
Fisher & Paykel Healthcare
Official's Role
Study Chair
Facility Information:
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31691105
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.
Results Reference
derived
Learn more about this trial
Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD
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