Clinical trial NCT05255744: Whitsundays (Nasal) Singapore External Clinical Study 1 Protocol
Official title: Assessment of the Seal, Comfort, Usability and Performance of the Prototype Whitsundays Nasal Mask System in the Singapore Home Environment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: ResMed
Sponsor class: INDUSTRY
Collaborators: name: Singapore General Hospital
First posted: 2022-02-24
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model 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.
Primary purpose: TREATMENT

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

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 Whitsundays nasal mask system will be compared with a released mask, ResMed's AirFit N30i Quiet, as it is also a nasal mask and the most appropriate benchmark. Study participants are experienced with CPAP masks and devices and therefore will use their experience to identify areas for potential improvement.

Recruitment will be done via phone calls/ SMS messages/ emails \<TBC with PI\>. Participants will be explained the details of the trial and those who wish to take part will be invited to a selected site for the first study visit.

Visit 1: Participants will provide written informed consent. Participants will be shown the mask systems and trial them for fit and comfort. Participants may be asked initial questions on their first thoughts on the mask systems. If the participant and assessor are happy to proceed, the participants will use the mask and loan CPAP for trial.

Visit 2: After trialing the mask systems, participants will be asked to complete a questionnaire regarding the seal and comfort of the mask system(s). Participants will then take the second mask system home to test.

Visit 3: The participant will return the masks and CPAP device to the assessor. The participants' questionnaire responses will be reviewed. This concludes the participation in the study.

Eligibility criteria: 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

Primary outcomes:
measure: Subjective usability
timeFrame: 6 weeks
measure: Apnea Hypopnea Index (Events/hour)
timeFrame: 6 weeks
Secondary outcomes:
measure: General Usability
timeFrame: 6 weeks
measure: Leak (L/minute)
timeFrame: 6 weeks
measure: CPAP Pressure (cmH2O)
timeFrame: 6 weeks
measure: Usage Hours (hours/night)
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
References: