RecruitingChronic Respiratory ConditionsObstructive Sleep Apnea (OSA)
Evaluation of the F&P Mask, US, 2026
Eligible age
22+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
See if you qualify for this study
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About this study
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.
Sponsor: Fisher and Paykel Healthcare
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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)
Where it's recruiting
Missouri
St Louis
Source: ClinicalTrials.gov · NCT07826429 · last updated 2026-10-16