TerminatedNot Applicable

Whitsundays (Nasal) Singapore External Clinical Study 1 Protocol

Stopped: The study was discontinued prior to initiation because startup activities could not be completed within the planned timelines.

Singapore30 participantsStarted 2025-03-28

Plain-language 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 to the ResMed AirFit N30i Quiet mask system (a benchmark mask) in relation to seal, comfort, usability, overall performance, and efficacy.

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 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. * Patients believed to be unsuitable for inclusion by the researcher

What they're measuring

Subjective usability

Timeframe: 6 weeks

Apnea Hypopnea Index (Events/hour)

Timeframe: 6 weeks

Trial details

NCT IDNCT05255744

SponsorResMed

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-06

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