Whitsundays (Nasal) Mask Take Home Study (90 Days)

Status Completed

Clinical Trial Summary

The goal of this multi-site, prospective, randomized, double arm study without blinding is to test the usability of the Whitsundays mask system at home by patients with Obstructive Sleep Apnea. The main questions it aims to answer are: - How the Whitsundays masks performs in the home environment - What is the subject's first impression of the Whitsundays mask and what is their preference compared to their own mask - What is the difference between the subject's objective therapy data when using the Whitsundays mask compared to their own mask - Is there wear and tear of the Whitsundays mask and how frequently do the cushions need replacement Participants will be asked to use the Whitsundays mask for 90 days, answer questionnaires about the initial impression of the mask, the performance of the mask, and their preference compared to their own mask. Researchers will compare one group of subjects who will be provided with cushion replacements to another group who will only be provided with cushion replacements upon request to determine the need for cushion replacement, its frequency, and the reasons for cushion replacement during home usage.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06036329
Study type	Interventional
Source	ResMed
Contact
Status	Completed
Phase	N/A
Start date	May 31, 2023
Completion date	November 6, 2023

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