The Evaluation of a Mask Seal/Mask for the Treatment of Obstructive Sleep Apnea (OSA)

The Evaluation of a Mask for the Treatment of Obstructive Sleep Apnea (OSA)

This investigation is designed to evaluate the performance as well as the patients overall acceptance of the seal/mask.

A minimum of 15 OSA participants who currently use a Full face mask will be recruited for the trial. Participant will be on the trial for 1 week- The participant will use the trial seal in-home for 1 week.

An additional 5 Participants will be added to the study to use the entire mask in home for 14+-4 days as an extension to the original trial.

Inclusion Criteria:

• Adult (18+ years of age)
• Able to give consent
• Apnea hypopnea Index (AHI)≥ 5 on diagnostic night
• Prescribed PAP for OSA
• Existing oro-nasal mask user

Exclusion Criteria:

• Inability to give consent
• Patients who are in a coma or a decreased level of consciousness
• Anatomical or physiological conditions making automatic positive airway pressure (APAP) therapy inappropriate (e.g. unconsolidated facial structure)
• Commercial drivers who are investigated by New Zealand Transport Agency
• Current diagnosis of carbon dioxide (CO2) retention
• Pregnant or may think they are pregnant