Post Market Clinical Follow up of ResMed Mask Systems
ConditionObstructive Sleep Apnea
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorResMed
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- New generation CPAP mask
Treatment groups
500 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov