Taking people in AustraliaNo phase
Post Market Clinical Follow up of ResMed Mask Systems
Key facts
- Who runs it
- ResMed
- Where
- Sydney, AustraliaSee the site
- Trial code
- Status
- Recruiting
- People taking part
- 500 people, planned
- Started
- 26 May 2022
- Expected to end
- Jun 2027
- Type of study
- Interventional
- Treatments tested
- New generation CPAP mask
- Record updated
- 29 April 2026
Who can take part
- Age
- 18 years to 100 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Participants willing to give written informed consent
- Participants who can read and comprehend English
- Participants who ≥ 18 years of age
- Participants being treated for OSA for ≥ 6 months
- Participants currently using a suitable mask system
- Participants currently using CPAP device compatible with AirView, or with download capacity from CPAP machine from data cards
Who cannot take part
- Participants who or whose bed partner has implantable metallic implants in the head, neck and chest region affected by magnetic fields (Non-ferrous implants may be acceptable) (for masks with magnetic clips only)
- Participants with a pre-existing 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
- Participants using Bilevel flow generators
- Participants who are or may be pregnant
- Participants believed to be unsuitable for inclusion by the researcher
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 100 years old?
Where in Australia
- Medical Affairs ResMedSydney, AustraliaContact: Jeff Armitstead, PhDTaking people
About the trial
What the trial wants to find out
Post Market follow up study to systematically and proactively collect supplementary real world data to confirm the usability and performance of the new generation mask systems. .
The group in the trial
- New generation CPAP maskTreatment being tested
The intended purpose of mask systems is to provide airflow from a CPAP device, through tubing, and to the patient. The air acts as a pneumatic splint to keep the airway open and prevent collapse during sleep. The masks to be used in this study are released masks approved and released.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT05262439, who can take part
- Record updated
- 29 April 2026