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

ResMed

Status

Completed

Conditions

Obstructive Sleep Apnea

Treatments

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

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT06036329

SLP-23-02-01

D638-1118 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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