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

NCT06036329 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-02-29

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Group A : provided with 1 Whitsundays Nasal mask without a spare mask cushion

Group A will be provided with 1 Whitsundays Nasal mask without a spare mask cushion (replacement cushions will only be provided when requested)

DEVICE

Group B : provided with 1 Whitsundays Nasal mask with 2 spare mask cushions

Group B will be provided with 1 Whitsundays Nasal mask with 2 spare mask cushions

Sponsors & Collaborators

  • ResMed

    lead INDUSTRY

Principal Investigators

  • William Hevener, RPSGT · Sleep Data

  • Matthew Uhles, MS · Clayton Sleep Institute

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-31
Primary Completion
2023-11-06
Completion
2023-11-06
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06036329 on ClinicalTrials.gov