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Auto Bilevel Adherence Following a Poor Initial Encounter With Continuous Positive Airway Pressure (CPAP)

NCT02522442 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2019-04-26

Study results available
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Summary

The primary objective outcome is the proportion of participants compliant (at least four hours of use per night for all nights) in the Auto Bilevel group compared to the continuous positive airway pressure (CPAP) group after 90 days of treatment during the investigation. Proportion will be calculated using the cumulative number of hours on therapy divided by the total number of days of the investigation for each participant. The mean and standard deviation of these mean therapy hours will then be calculated for each arm of the investigation. Participants with compliance of at least four hours will be classified as "compliant" and those with less than four hours will be classified as "non-compliant". The null hypothesis will be rejected if the mean of the primary objective outcome for all participants in the BiPAP® Auto with Bi-Flex® therapy (auto Bilevel) arm is significantly greater than that for all participants in the CPAP therapy arm

Conditions

Interventions

DEVICE

CPAP

Continuous positive airway pressure

DEVICE

Auto BiLevel

Auto Bilevel positive airway pressure with Flex

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Brigham and Women's Hospital

    collaborator OTHER

  • Philips Respironics

    lead INDUSTRY

Principal Investigators

  • Eric Powell, Ph.D. · Philips Respironics

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-01-31
Completion
2009-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT02522442 on ClinicalTrials.gov