CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 45 enrolled
Drug / intervention
Device: Trial nasal mask (F&P)device
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/NCT04011826
NCT04011826N/ACompleted

The Evaluation of a New Nasal Mask for the Treatment of Obstructive Sleep Apnea

Fisher and Paykel Healthcare·interventional·Posted Jul 9, 2019·Updated Dec 1, 2021

In Brief

A clinical study evaluating Device: Trial nasal mask (F&P) for Obstructive Sleep Apnea. Completed, enrolled 45 participants across 1 site.

Detailed Summary

This investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of Obstructive Sleep Apnea (OSA) in the home environment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJul 9, 2019
Enrollment StartAug 5, 2019
Primary CompletionApr 30, 2020
Study CompletionAug 30, 2020
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 7.0 years ago

Interventions

Device: Trial nasal mask (F&P)device

This trial nasal mask will serve as the participant's primary PAP/BPAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial nasal mask as their primary PAP/BPAP therapy mask for 6 months after Visit 3.