Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea

This clinical trial is designed to evaluate the performance, comfort, and usability of a new nasal pillows mask for the treatment of obstructive sleep apnea (OSA) in a home environment.

Inclusion Criteria:

• Are ≥22 years of age
• Weigh ≥66 lbs
• Have been formally diagnosed with OSA by a physician
• Have an AHI ≥5 on a diagnostic night
• Have been prescribed PAP therapy to treat OSA by a physician
• Are an existing nasal pillows mask user
• Have been using a nasal pillows mask for ≥3 months prior to enrolment into the study
• Are compliant with PAP therapy for ≥4 hours per night for 70% of nights
• Are fluent in spoken and written English
• Possess the capacity to provide informed consent

Exclusion Criteria:

• Are intolerant to PAP therapy
• Possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
• Are currently diagnosed with respiratory disease or CO2 retention
• Are pregnant or think they may be pregnant
• Have an IPAP pressure of >25 cmH2O
• Persons who use a PAP therapy machine for the delivery of medicines, except O2
• Use a PAP therapy machine that does not possess data recording capabilities to capture AHI and leak information that is accessible to OSMI