| NCT ID | NCT07826429 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fisher and Paykel Healthcare |
| Condition | Chronic Respiratory Conditions |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2026-09-28 |
| Primary Completion | 2027-04-21 |
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 45 participants in total. It began in 2026-09-28 with a primary completion date of 2027-04-21.
⚠ 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
This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F\&P PAP mask in a home environment.
Eligibility Criteria
Inclusion Criteria: * Are ≥22 years of age * Weigh ≥66 pounds * Have been prescribed PAP/NIV therapy by a physician * Are an existing PAP/NIV therapy mask user with ≥3 months of use prior to enrolment in the clinical investigation\* * Are compliant with PAP/NIV therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical investigation * Are fluent in spoken and written English * Possess the capacity to provide informed consent Exclusion Criteria: * Are intolerant to PAP/NIV therapy * Possess, or suffer from, anatomical or physiological conditions which make PAP/NIV therapy inappropriate * Are required to use PAP/NIV therapy for \>12 hours per day or for extensive periods, not including sleep or naps * Are trying to get pregnant, are pregnant, or think they may be pregnant * Have an IPAP pressure of \>30 cmH2O if on BPAP * Use a PAP/NIV therapy device for the delivery of medicines, except supplemental O2 * Use a PAP/NIV therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the clinical investigation site * Have a history of light-induced seizures (for optional anthropometric scan only)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07826429 clinical trial?
This trial is open to participants of all sexes, aged 22 Years or older, studying Chronic Respiratory Conditions. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07826429 currently recruiting?
Yes, NCT07826429 is actively recruiting participants. Contact the research team at cpap.trial@fphcare.co.nz for enrollment information.
Where is the NCT07826429 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT07826429 clinical trial?
NCT07826429 is sponsored by Fisher and Paykel Healthcare. The trial plans to enroll 45 participants.