Whitsundays (Nasal) Singapore External Clinical Study 1 Protocol
NCT ID: NCT05255744
Last Updated: 2023-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2024-03-28
2024-05-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Whitsundays nasal mask
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.
Positive Airway Pressure (PAP) Therapy
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.
AirFit N30i Quiet mask
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.
Positive Airway Pressure (PAP) Therapy
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.
Interventions
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Positive Airway Pressure (PAP) Therapy
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
21 Years
ALL
Yes
Sponsors
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Singapore General Hospital
OTHER
ResMed
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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SLP-21-11-01
Identifier Type: -
Identifier Source: org_study_id
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