CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 38 enrolled
Drug / intervention
Toffee full face mask with 'Improved Seal' +1 moredevice
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/NCT03230877
NCT03230877N/ACompleted
CompareCT.gov

The Evaluation of a Full Face Mask Seal for the Treatment of Obstructive Sleep Apnea

Fisher and Paykel Healthcare·interventional·Posted Jul 27, 2017·Updated Sep 8, 2022

In Brief

A clinical study evaluating Toffee full face mask with 'Improved Seal' and Toffee full face mask with 'Normal Seal' for Obstructive Sleep Apnea. Completed, enrolled 38 participants across 1 site.

Detailed Summary

The investigation is a prospective, randomized, single blinded, crossover study. The investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Trial Full Face Mask Seal amongst Obstructive Sleep Apnea (OSA) participants. A total number of 40-45 OSA participants will be recruited for the trial by the investigation site

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObstructive Sleep Apnea
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJul 27, 2017
Enrollment StartSep 2, 2017
Primary CompletionNov 30, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 8.9 years ago

Interventions

Toffee full face mask with 'Improved Seal'device

Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Improved Seal in this treatment arm.

Toffee full face mask with 'Normal Seal'device

Participants will be randomized to this arm for a total of 7 ± 4 days from visit 1. Participants will be using the Normal Seal in this treatment arm.