Evaluation of the F&P Mask, US, 2026

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)