Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea

Evaluation of a Full Face Mask and Headgear for the Treatment of Obstructive Sleep Apnea

Currently Fisher & Paykel Healthcare (FPH) is developing a new full face mask. The objective of this clinical investigation is to evaluate the usability and acceptance of the investigative mask, the effectiveness of the seal and headgear.

The participant will be randomised to use either full face mask prototype 1 or 2 as according to the randomization log for 7 ± 3 days in home. The participant will then crossover to the other full face mask prototype to use in home for 7 ± 3 days. Neither the investigators or the participants will be blinded to the study.

Inclusion Criteria:

• AHI ≥ 5 from the diagnostic night
• ≥ 18 years of age
• Either prescribed APAP or CPAP or Bi level for OSA
• Existing full face users

Exclusion Criteria:

• Inability to give informed consent
• Participant intolerance to PAP
• Anatomical or physiological conditions making PAP therapy inappropriate
• Current diagnosis of respiratory disease or CO2 retention
• Pregnant or think they may be pregnant