A Development Study to Evaluate a Full-Face Mask for the Treatment of Obstructive Sleep Apnea

This investigation is a prospective, non-randomized, non-blinded study. Up to 45 OSA
participants who currently use a full-face mask will be recruited.

This study will involve a baseline (Visit One) data gathering with the participant's PAP
therapy and their usual mask. This will be followed by the participants being fitted with the
trial full-face mask for use in-home (Visit Two).

The participant then will come in to return the mask (Visit Three) and give their feedback on
their experience using the mask in home in the form of a structured interview during Visit
Three. The maximum amount of time the participants will be exposed to the trial mask in-home
will be 14 ± 5 days from Visit Two.

The mask and CPAP (if used from the research pool) will be returned to the institution at the
conclusion of the trial and participant will return to their usual mask and therapy device
for the treatment of their Obstructive Sleep Apnea.

Neither the investigators nor the participants will be blinded to the study.

Inclusion Criteria:

- AHI ≥ 5 from the diagnostic night

- Aged 22 and over (FDA defined as default)

- Either prescribed APAP, CPAP or Bi-level PAP for OSA

- Existing Full-Face mask user

- Fluent in spoken and written English

Exclusion Criteria:

- Inability to give informed consent

- Participant intolerant 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