CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 49 enrolled
Drug / intervention
PAP devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02214238
NCT02214238N/ACompleted

Evaluation of Treatment Efficacy and Comfort of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea, in Comparison to a Market Released Device.

Fisher and Paykel Healthcare·interventional·Posted Aug 12, 2014·Updated Apr 24, 2017

In Brief

A clinical study evaluating PAP device for Obstructive Sleep Apnea (OSA). Completed, enrolled 49 participants across 1 site.

Detailed Summary

This study will test the hypothesis that the modified positive airway pressure (PAP) device for OSA will be no worse than a market released product in terms of its treatment efficacy, comfort and patient compliance. Patients will have their treatment pressure titrated using polysomnography (PSG) in the sleep laboratory, and then in a random order will spend additional time undergoing PSG using both devices, and using both devices at home for 3 weeks. Data will be collected from the PSG studies, device downloads, independent pressure-flow loggers, and custom questionnaires.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNew Zealand
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 12, 2014
Enrollment StartAug 1, 2014
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 11.9 years ago

Interventions

PAP devicedevice