Whitsundays (Nasal) Singapore External Clinical Study 1 Protocol

Study Overview
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Brief Summary
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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
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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.

Official Title
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Assessment of the Seal, Comfort, Usability and Performance of the Prototype Whitsundays Nasal Mask System in the Singapore Home Environment

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Positive Airway Pressure (PAP) Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whitsundays nasal mask<br>Participants will be asked to take home the investigational mask to use at night while they sleep in place of their own mask. The participant's therapy and comfort settings will not be altered. | Device: Positive Airway Pressure (PAP) Therapy<br>* PAP therapy supplies pressurized air from the flow generator to the upper airway via air tubing and a mask to prevent the repetitive collapse of the upper airway during sleep.<br>|
| Active Comparator: AirFit N30i Quiet mask<br>Participants will be asked to take home the comparator mask to use at night while they sleep in place of their own mask. The participant's therapy and comfort settings will not be altered. | Device: Positive Airway Pressure (PAP) Therapy<br>* PAP therapy supplies pressurized air from the flow generator to the upper airway via air tubing and a mask to prevent the repetitive collapse of the upper airway during sleep.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective usability | Comparison of the seal, comfort, usability and overall preference of the Whitsundays nasal mask system to the AirFit N30i Quiet mask system and/or Criterion Score of 6 | 6 weeks | 
| Apnea Hypopnea Index (Events/hour) | Objective AHI taken from the participant's CPAP device used during the trial, with a comparison of the Whitsundays nasal mask to the benchmark AirFit N30i Quiet mask or clinically relevant data. nasal mask system to the AirFit N30i Quiet mask system and/or Criterion Score of 6 | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General Usability | General subjective usability scores from participant. Each usability items of the Whitsundays Nasal Mask System and AirFit N30i Quiet Mask System will be rated on a Likert Scare questionnaire. A score of 10 is considered very favourable whereas score of 0 is considered very unfavourable. | 6 weeks | 
| Leak (L/minute) | Calculated leak from the CPAP device provides information on how well the Whitsundays Nasal Mask and AirFit N30i Quiet Mask fit on the patient. | 6 weeks | 
| CPAP Pressure (cmH2O) | Calculated average pressure from the CPAP device, which indicates how much pressure patients need to keep the airway open. | 6 weeks | 
| Usage Hours (hours/night) | Average usage hours taken from the participants' CPAP device used during the study. | 6 weeks |