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