Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-24 @ 4:25 PM
NCT ID:
NCT06079866
Eligibility Criteria:
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 ≥ 12 months
* Participants who have met CMS compliance for CPAP therapy over the last 3 months
* Participants who have been using a ResMed cloud connected AirSense10 or AirSense 11 device compatible with AirView, for more than 12 months
* Participants currently using a suitable mask system\*
* Participants who can trial the masks for up to 7 nights each
* Note\*: Suitable mask system includes any tube down full face mask (e.g. AirFit F30, AirFit F20, AirTouch F20, AirFit F10, Quattro Air, Quattro Fx, Mirage Quattro, Simplus, Amara, Amara Gel, Comfort gel Full Face Mask, Evora Full)
Exclusion Criteria:
* Participants using Bi-level 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 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)
* Participants who use a rental unit for AirSense 10 or AirSense 11 device
* Participants believed to be unsuitable for inclusion by the researcher
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06079866
Study Brief:
Protocol Section:
NCT06079866