Evaluation of the Toffee Nasal and Toffee Nasal Pillows Mask in Home, USA, 2022

This clinical investigation is designed to assess the F&P Toffee Nasal and Toffee Nasal Pillows masks in home for use during PAP therapy delivery. A target recruitment goal of 45, current PAP therapy users per mask type (e.g. Nasal and Nasal Pillows) will be recruited to participate in this investigation to achieve a total sample of 90. The investigation will involve participation in a two week in home trial of the F&P Toffee Nasal or Toffee Nasal Pillows mask.

The objectives of the investigation are to assess therapeutic efficacy, safety and comfort.

Inclusion criteria

• Persons who are ≥ 22 years of age
• Persons who weigh ≥ 66 lbs (30 kgs)
• Persons who have been prescribed PAP (APAP, BPAP or CPAP) therapy by a physician
• Persons who are compliant with PAP therapy for ≥ 4 hours per night for 70% of nights for at least two weeks prior to enrolment in the trial
• Persons who are currently using either a nasal, sub-nasal or nasal pillows mask
• Persons who have an IPAP pressure of < 20 cmH2O
• Persons who currently use a PAP therapy device with data recording capabilities
• 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 are required to use PAP therapy for more than 12 hours per day or for extensive periods other than sleep or naps
• Persons using full face masks
• Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
• Persons who are pregnant or think they may be pregnant
• Persons who use a PAP therapy machine for the delivery of medicines, except supplemental O2