New generation CPAP mask: All participants entered into the study will be couriered a new generation ResMed mask system to be used with their own CPAP machine and in place of their own mask.
Study summary
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. .
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* Participants using Bilevel flow generators
* Participants who are or may be pregnant
* 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 believed to be unsuitable for inclusion by the researcher
* 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)
Primary outcome measure(s)
Apnea Hypopnea Index (event/hour) — up to 90 days Apnea Hypopnea events per hour taken from the participant's CPAP device used during the study
Usage Hours (hours/night) — up to 90 days Average usage hours taken from the participant's CPAP device used during the study
Leak (L/minute) — up to 90 days Calculated leak from CPAP machine which assess how well mask seals on patients
CPAP Pressure (cmH2O) — up to 90 days Calculated average pressure from the CPAP machine which indicates how much pressure patients required to keep their airway open
Adverse Events — up to 90 days Device related adverse events during the study period will also be assessed.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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