CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
Toffee Full Face Maskdevice
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/NCT03726346
NCT03726346N/ACompleted

The Evaluation of the Toffee Mask for the Treatment of Obstructive Sleep Apnea

Fisher and Paykel Healthcare·interventional·Posted Oct 31, 2018·Updated Jun 21, 2022

In Brief

A clinical study evaluating Toffee Full Face Mask for Obstructive Sleep Apnea. Completed, enrolled 39 participants across 1 site.

Detailed Summary

This investigation is a prospective, non-randomized, non-blinded study. This investigation is designed to evaluate the performance, comfort and ease of use of the F\&P Toffee mask amongst Obstructive Sleep Apnea (OSA) patients. Up to 45 OSA patients will be recruited from the Pulmonary Disease Specialists Research database.

Study Details

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

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 31, 2018
Enrollment StartNov 26, 2018
Primary CompletionDec 13, 2018
Study CompletionNov 13, 2019
TodayJul 2, 2026
Enrollment to primary: 17 daysPosted 7.7 years ago

Interventions

Toffee Full Face Maskdevice

Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.