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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-31

Study Completion Date

2023-11-06

Brief Summary

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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.

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Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

• Provided with 1 Whitsundays Nasal mask without a spare mask cushion (To be provided as requested)

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

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

• Provided with 1 Whitsundays Nasal mask with 2 spare mask cushions

Group Type EXPERIMENTAL

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

Intervention Type DEVICE

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

Interventions

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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)

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients willing to give written informed consent
* Patients who can read and comprehend English
* Patients who ≥ 18 years of age
* Patients being treated for OSA with a PAP device for ≥ 6 months
* Patients currently using a ResMed PAP device (S9, AirSense 10 \& AirSense 11) compatible with AirView (with cellular data connectivity and has been sending device data to the cloud)
* Patients currently using ResMed AirFit N30i or Philips DreamWear™ Nasal
* Patients who are willing to try the prototype mask for up to 90 nights
* Patients who are willing to take photos of the prototype mask every 2 weeks for the duration of the study
* Patients who reside in the USA and intend to stay in the USA for the next 6 months
* Patients with access to the internet (such as a smartphone or laptop) to complete online surveys

Exclusion Criteria

* Patients using Bilevel flow generators
* Patients who are or may be pregnant
* Patients with a preexisting lung disease/condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury.
* If you are pregnant or planning to become pregnant
* Patients believed to be unsuitable for inclusion by the researcher

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No