Status:
COMPLETED
Whitsundays (Nasal) Mask Take Home Study (90 Days)
Lead Sponsor:
ResMed
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ma...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 6 2023
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06036329
Start Date
May 31 2023
End Date
November 6 2023
Last Update
February 29 2024
Active Locations (2)
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1
Sleep Data
San Diego, California, United States, 92123
2
Clayton Sleep Institute
St Louis, Missouri, United States, 63123