Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02549508
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02549508
Recruitment Status : Completed
First Posted : September 15, 2015
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Fisher and Paykel Healthcare

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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea (OSA) Post-Traumatic Stress Disorder (PTSD) Device: AutoCPAP with SensAwake On Device: AutoCPAP with SensAwake Off Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 87 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison Study Using APAP With and Without SensAwake in Patients With OSA and PTSD
Actual Study Start Date : October 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AutoCPAP with SensAwake On
The comfort feature 'SensAwake' will be turned on whilst participants continue to receive PAP therapy
Device: AutoCPAP with SensAwake On
The comfort feature 'SensAwake' will be turned on

Active Comparator: AutoCPAP with SensAwake Off
The comfort feature 'SensAwake' will be turned off whilst participants continue to receive PAP therapy
Device: AutoCPAP with SensAwake Off
The comfort feature 'SensAwake' will be turned off




Primary Outcome Measures :
  1. Adherence (Hours on therapy) [ Time Frame: 4 weeks ]
    Hours per night averaged over total time period measured.


Secondary Outcome Measures :
  1. Sleep Quality (Epworth Sleepiness Scale (ESS) [ Time Frame: 8 hours ]
    ESS; 0-9 Normal, 11-15 Mild, 16+ Possibility of Severe Sleep Apnea.

  2. Insomnia Severity Index (ISI) [ Time Frame: 8 hours ]
    ISI; 0-7 = No clinically significant insomnia, 8-14 = Sub threshold insomnia, 15-21 = Clinical insomnia (moderate severity), 22-28 = Clinical insomnia (severe).

  3. Sleep Diary completion [ Time Frame: 8 hours ]
    subjective sleep quality



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02549508


Locations
Layout table for location information
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
Sponsors and Collaborators
Fisher and Paykel Healthcare
Investigators
Layout table for investigator information
Principal Investigator: Aaron B Holley, MD Walter Reed National Military Medical Center
Study Chair: Rebecca Thomson, MA Fisher & Paykel Healthcare

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT02549508     History of Changes
Other Study ID Numbers: CIA 134
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Sleep Apnea, Obstructive
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Trauma and Stressor Related Disorders
Mental Disorders