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Evaluation of Treatment Efficacy of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea

NCT02971436 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2018-08-02

No results posted yet for this study

Summary

This study will investigate the efficacy of the FPH modified positive airway pressure (PAP) device with or without SensAwake; and with different pressure support in OSA participants; in both an in-home and in-lab environment. Comfort, compliance and the accuracy of the pressure delivery will also be evaluated. The FPH device will be compared to a market released product.

Conditions

Interventions

DEVICE

FPH Device with SensAwake On + Pressure Support A

FPH Device with SensAwake On + Pressure Support A

DEVICE

FPH Device with SensAwake Off + Pressure Support A

FPH Device with SensAwake Off + Pressure Support A

DEVICE

FPH Device with SensAwake On + Pressure Support B

FPH Device with SensAwake On + Pressure Support B

DEVICE

FPH Device with SensAwake Off + Pressure Support B

FPH Device with SensAwake Off + Pressure Support B

DEVICE

Competitor's PAP Released Device + Pressure Support A

Competitor's PAP Released Device + Pressure Support A

DEVICE

Competitor's PAP Released Device + Pressure Support B

Competitor's PAP Released Device + Pressure Support B

Sponsors & Collaborators

  • Fisher and Paykel Healthcare

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-08-31
Completion
2017-08-31

Countries

  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

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 NCT02971436 on ClinicalTrials.gov