A Study to Determine Preferences Towards Interface Products

A Study to Determine Clinician and Patient Preferences Towards Interface Products Recommended by the 3D Mask Advice Tool

Enrolled Naïve participants will be randomized to one of two arms, the investigational or control arm. Once randomized the institutions will fit the participant with the procedures outlined in the protocol. Each participant will be required to trial the mask for a period of 90 days. Any Unscheduled Visits or Calls that occur during the participants 90 days documented.

Inclusion Criteria:

• Adult Volunteers (ages 21-85)
• Willing and able to provide informed consent
• Able to follow instructions
• Able to read and speak in English as their primary language
• Currently diagnosed with Sleep Apnea through an in-lab sleep (polysomnography (PSG)) or home sleep testing, but has not started therapy and/or been fit with a mask.

Exclusion Criteria:

• Pre-existing conditions such as bullous lung disease, pathologically low blood pressure, bypassed upper airway, pneumothorax, pneumocephalus, cerebral spinal fluid (CSF) leaks, cribriform plate abnormalities, and prior history of head trauma that has resulted in current cognitive dysfunction.
• Prescribed an Adaptive Servo Ventilation (ASV) device
• The presence of physical or mental limitations that would limit the ability to test the mask.
• Obstructive Sleep Apnea (OSA) diagnosis achieved through a split night sleep study
• Known allergy to silicone
• Unique facial features (i.e. deformities of the face and/or head, piercings, etc) that could interfere with the use of masks.
• Employee of Philips or spouse of a Philips employee
• Currently participating in another interventional research study or planned participation in another interventional research study during the trial period (by self-report)
• Surgery involving the eyes, ears, nose, sinuses, or upper airway within the last 90 days.
• Planned surgical procedures involving the head, neck, face (eyes, ears, nose), or lung during the trial period.
• Uncontrolled or poorly managed gastroesophageal reflux
• Impaired cough reflex
• Untreated or symptomatic hiatal hernia
• Untreated glaucoma
• Untreated chronic dry eyes
• Unable to remove the sleep apnea mask without the assistance of others
• Use of prescription drugs that induce vomiting