A Study to Determine Preferences Towards Interface Products

Philips

Status

Completed

Conditions

Sleep Disorder; Breathing-Related

Treatments

Other: Standard of Care

Other: Mask Advice Tool

Study type

Interventional

Funder types

Industry

Identifiers

NCT03948152

SRC-SLE(PI)-CP-2018-10129

Details and patient eligibility

About

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.

Enrollment

310 patients

Sex

All

Ages

21 to 85 years old

Volunteers

No Healthy Volunteers

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