Post Market Clinical Follow up of ResMed Mask Systems

Post Market Clinical Follow up of ResMed Mask Systems

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. .

This is an open label, prospective, multi-centre, single arm study for post market clinical follow up. The study will be conducted in the home environment remotely. Eligible participants currently using older generations of CPAP masks will use the new generation ResMed mask system in the same mask category to their own (nasal, full face, pillow) in place of their own mask for 90 nights and complete a series of questionnaires at specified study checkpoints.

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)