Status:
UNKNOWN
Whitsundays (Nasal) Singapore External Clinical Study 1 Protocol
Lead Sponsor:
ResMed
Collaborating Sponsors:
Singapore General Hospital
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
Each Whitsunday mask or AirFit N30i Quiet mask is worn for 7 nights. The overall purpose of this study is to evaluate the performance of the Whitsundays nasal mask system (a prototype mask) compared t...
Detailed Description
This is a randomized, open label, cross over study to evaluate the Whitsundays nasal mask system (prototype mask) against a released mask system, the ResMed AirFit N30i Quiet mask system. The Whitsun...
Eligibility Criteria
Inclusion
- Patients willing to give written informed consent
- Patients who can read and comprehend English
- Patients who ≥ 21 years of age
- Patients being treated for OSA with PAP therapy for ≥ 6 months
- Patients currently using a suitable mask system (any nasal mask )
- Patients who can trial the masks for up to 7 nights each
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.
- Patients believed to be unsuitable for inclusion by the researcher
Key Trial Info
Start Date :
March 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05255744
Start Date
March 28 2024
End Date
May 31 2024
Last Update
October 23 2023
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