Follow up on the performance of new ResMed CPAP masks
Post Market Clinical Follow up of ResMed Mask Systems
This study is testing new ResMed CPAP masks to see how well they work for people with obstructive sleep apnea who are currently using older masks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | ResMed Industry-sponsored |
| Locations | 1 site (Sydney, New South Wales) |
| Trial ID | NCT05262439 on ClinicalTrials.gov |
What this trial studies
This study aims to collect real-world data on the usability and performance of new generation ResMed mask systems for patients with obstructive sleep apnea. Participants currently using older CPAP masks will switch to the new masks for 90 nights and complete questionnaires at various checkpoints to assess their experience. The study is conducted remotely in participants' home environments, allowing for a comprehensive evaluation of the new mask systems in everyday use.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have been treated for obstructive sleep apnea for at least 6 months and are currently using a compatible CPAP mask.
Not a fit: Patients using bilevel flow generators or those with certain pre-existing lung conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the comfort and effectiveness of CPAP therapy for patients with obstructive sleep apnea.
How similar studies have performed: Other studies have shown success in evaluating new CPAP devices, indicating that this approach is supported by previous research.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Sydney, New South Wales
- Medical Affairs ResMed — Sydney, New South Wales, Australia (Recruiting)
Study contacts
- Principal investigator: Jeff Armistead, PhD — ResMed
- Study coordinator: Xueling Zhu, BHSc (Nursing), RN
- Email: Xueling.Zhu@resmed.com.au
- Phone: 02 8884 2265
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.