Obstructive Sleep ApneaNCT05255744
Whitsundays (Nasal) Singapore External Clinical Study 1 Protocol
A study testing Positive Airway Pressure (PAP) Therapy in people with Obstructive Sleep Apnea, run by ResMed at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Positive Airway Pressure (PAP) Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- 28 Mar 2025to 31 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Positive Airway Pressure (PAP) Therapy
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Airway Pressure (PAP) TherapyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Whitsundays nasal mask | Experimental | 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. Receives: Device: Positive Airway Pressure (PAP) Therapy |
| AirFit N30i Quiet mask | Active comparator | 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. Receives: Device: Positive Airway Pressure (PAP) Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 6 weeks
CPAP Pressure (cmH2O)
Calculated average pressure from the CPAP device, which indicates how much pressure patients need to keep the airway open.
Measured: 6 weeks
Usage Hours (hours/night)
Average usage hours taken from the participants' CPAP device used during the study.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study start28 Mar 2025
- Primary completion6 May 2025
- Study completion31 May 2025
Why it stopped: The study was discontinued prior to initiation because startup activities could not be completed within the planned timelines.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by ResMedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- ResMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Singapore General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255744
- Sponsor's protocol ID
- SLP-21-11-01
- Status last verified
- Apr 2026
- First submitted
- 14 Dec 2021
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Seal, Comfort, Usability and Performance of the Prototype Whitsundays Nasal Mask System in the Singapore Home Environment
- ClinicalTrials.gov ID
- NCT05255744
- Acronym / sponsor ID
- SLP-21-11-01
- Conditions
- Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was discontinued prior to initiation because startup activities could not be completed within the planned timelines.
- Enrolment
- 30 participants (actual)
- Lead sponsor
- ResMedIndustry (pharma, biotech, devices)
- Collaborators
- Singapore General Hospital
- Study start
- 28 Mar 2025 (actual)
- Primary completion
- 6 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Whitsundays nasal mask | Experimental | Device: Positive Airway Pressure (PAP) TherapyParticipants 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. |
| AirFit N30i Quiet mask | Active comparator | Device: Positive Airway Pressure (PAP) TherapyParticipants 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 )
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Airway Pressure (PAP) TherapyPAP 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. | Device | AirFit N30i Quiet mask, Whitsundays nasal mask |
Primary outcome
Subjective usability
Time frame: 6 weeks
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
Apnea Hypopnea Index (Events/hour)
Time frame: 6 weeks
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
4 secondary outcomes
General Usability
Time frame: 6 weeks
Leak (L/minute)
Time frame: 6 weeks
CPAP Pressure (cmH2O)
Time frame: 6 weeks
Usage Hours (hours/night)
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: The study was discontinued prior to initiation because startup activities could not be completed within the planned timelines.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Airway Pressure (PAP) Therapy in people with Obstructive Sleep Apnea, run by ResMed at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was discontinued prior to initiation because startup activities could not be completed within the planned timelines.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective usability (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2026.