Evaluation of F&P Mask, US, 2026

This clinical investigation is designed to validate and confirm the overall performance, safety, usability, reliability, and acceptability of the F\&P mask in a home environment.

Inclusion Criteria: * Are ≥22 years of age * Weigh ≥66 pounds * Have been prescribed PAP/NIV therapy by a physician * Are an existing PAPNIV 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: * 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)