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

NCT ID: NCT02549508

Last Updated: 2020-11-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-05-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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AutoCPAP with SensAwake On, then SenAwake Off

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.

Group Type EXPERIMENTAL

AutoCPAP with SensAwake On

Intervention Type DEVICE

The comfort feature 'SensAwake' will be turned on

AutoCPAP with SensAwake Off

Intervention Type DEVICE

The comfort feature 'SensAwake' will be turned off

AutoCPAP with SensAwake Off, then SensAwake On

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.

Group Type EXPERIMENTAL

AutoCPAP with SensAwake On

Intervention Type DEVICE

The comfort feature 'SensAwake' will be turned on

AutoCPAP with SensAwake Off

Intervention Type DEVICE

The comfort feature 'SensAwake' will be turned off

Interventions

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AutoCPAP with SensAwake On

The comfort feature 'SensAwake' will be turned on

Intervention Type DEVICE

AutoCPAP with SensAwake Off

The comfort feature 'SensAwake' will be turned off

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Aaron B Holley, MD

Role: PRINCIPAL_INVESTIGATOR

Walter Reed National Military Medical Center

Rebecca Thomson, MA

Role: STUDY_CHAIR

Fisher & Paykel Healthcare

Locations

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Walter Reed National Military Medical Center

Bethesda, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 31691105 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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CIA 134

Identifier Type: -

Identifier Source: org_study_id