NCT05262439 Post Market Clinical Follow up of ResMed Mask Systems
| NCT ID | NCT05262439 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ResMed |
| Condition | Obstructive Sleep Apnea |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2022-05-26 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2022-05-26 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 ≥ 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)
Contact & Investigator
Jeff Armistead, PhD
PRINCIPAL INVESTIGATOR
ResMed
Frequently Asked Questions
Who can join the NCT05262439 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Obstructive Sleep Apnea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05262439 currently recruiting?
Yes, NCT05262439 is actively recruiting participants. Contact the research team at Xueling.Zhu@resmed.com.au for enrollment information.
Where is the NCT05262439 trial being conducted?
This trial is being conducted at Sydney, Australia.
Who is sponsoring the NCT05262439 clinical trial?
NCT05262439 is sponsored by ResMed. The principal investigator is Jeff Armistead, PhD at ResMed. The trial plans to enroll 500 participants.