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

NCT02549508 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2020-11-10

Study results available
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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.

Conditions

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

Interventions

DEVICE

AutoCPAP with SensAwake On

The comfort feature 'SensAwake' will be turned on

DEVICE

AutoCPAP with SensAwake Off

The comfort feature 'SensAwake' will be turned off

Sponsors & Collaborators

  • Fisher and Paykel Healthcare

    lead INDUSTRY

Principal Investigators

  • Aaron B Holley, MD · Walter Reed National Military Medical Center

  • Rebecca Thomson, MA · Fisher & Paykel Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-03-31
Completion
2018-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02549508 on ClinicalTrials.gov