Whitsundays (Nasal) Mask Take Home Study (90 Days)
Completed · Not applicable
Conditions studied: Obstructive Sleep Apnea
In brief
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.
Key facts
- Study ID
- NCT06036329
- Run by
- ResMed
- People needed
- 120
- Starts
- 2023-05-31
- Expected to finish
- 2023-11-06
- Last updated by the study team
- 2024-02-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Sleep Data — San Diego, California, United States
- Clayton Sleep Institute — St Louis, Missouri, United States
Full record on ClinicalTrials.gov
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