NCT07826429NARecruiting
Evaluation of the F&P Mask, US, 2026
Fisher and Paykel Healthcare
Start Date
9/28/2026
Completion Date
6/21/2027
Summary
This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F\&P Licorice mask in a home environment.
Eligibility Criteria
Age Range: 22 years to No maximum
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)
Interventions
DEVICE
F&P Licorice Mask
Conditions
Chronic Respiratory ConditionsObstructive Sleep Apnea (OSA)
Locations
Clayton Sleep Institute
St Louis, Missouri 63123
United States