Whitsundays (Nasal) Singapore External Clinical Study 1 Protocol
Megadott ok: The study was discontinued prior to initiation because startup activities could not be completed within the planned timelines.
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A vizsgálat adatai
- Ki végzi
- ResMed
- Azonosító
- NCT05255744
- A regiszteradat frissítve
- 2026. április 27.
- Eredeti leírás
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 to the ResMed AirFit N30i Quiet mask system (a benchmark mask) in relation to seal, comfort, usability, overall performance, and efficacy.A teljes eredeti leírásKevesebb
Assessment of the Seal, Comfort, Usability and Performance of the Prototype Whitsundays Nasal Mask System in the Singapore Home Environment
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 to the ResMed AirFit N30i Quiet mask system (a benchmark mask) in relation to seal, comfort, usability, overall performance, and efficacy.
Bevonási feltételek: 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.
Kizáró feltételek: 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 using Bilevel flow generators; Patients who are or may be pregnant; Patients believed to be unsuitable for inclusion by the researcher.