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

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

The purpose of this clinical investigation is to evaluate the performance and safety of the F&P Caramel nasal mask in a home environment.

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