Investigative Headgear With Nasal Pillows Continuous Positive Airway Pressure (CPAP) Mask

Investigative Headgear With Nasal Pillows CPAP Mask

This investigation is designed to evaluate the at-home usability, performance, user acceptance and reliability of the headgear with a CPAP mask for a duration of 6 months.

20 participants will be recruited for the trial, consisting of male and female participants diagnosed with OSA and receiving CPAP or Bi-level Positive airway pressure (PAP) for the treatment of their Obstructive Sleep Apnea (OSA). These include current CPAP mask users.

Inclusion Criteria:

• AHI≥5 from the diagnostic night
• ≥18 years of age
• Prescribed CPAP or Bi-level therapy for OSA
• Existing F&P Pilairo Q, Eson, Simplus mask users

Exclusion Criteria:

• Inability to give informed consent
• Patient intolerant to CPAP
• Anatomical or physiological conditions making CPAP therapy inappropriate
• History of respiratory disease or carbon dioxide (CO2) retention
• Pregnant or think they may be pregnant
• Investigated by Land Transport Safety Authority