Evaluation of the F&P Caramel Nasal Mask, US, 2023

Inclusion Criteria: * Persons who are ≥22 years of age * Persons who weigh ≥66 pounds * Persons who have been prescribed PAP therapy by a physician * Persons who are existing nasal mask or sub-nasal mask users with ≥3 months of use prior to enrolment in the clinical trial * Persons who are compliant with PAP therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical trial * Persons who are fluent in spoken and written English * Persons who possess the capacity to provide informed consent Exclusion Criteria: * Persons who are intolerant to PAP therapy * Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate * Persons who are required to use PAP therapy for \>12 hours per day or for extensive periods, not including sleep or naps * Persons who are trying to get pregnant, are pregnant, or think they may be pregnant * Persons who have an IPAP pressure of \>30 cmH2O if on BPAP * Persons who use a PAP therapy device for the delivery of medicines, except supplemental oxygen * Persons who use a PAP therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the investigation site