A Study to Determine Preferences Towards Interface Products

Completed · Not applicable

Conditions studied: Sleep Disorder; Breathing-Related

In brief

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.

Key facts

Study ID

NCT03948152

Run by

Philips Respironics

People needed

310

Starts

2019-04-18

Expected to finish

2020-02-07

Last updated by the study team

2020-07-07

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Pulmonary Disease Specialists, PA, d/b/a PDS Research — Kissimmee, Florida, United States
• Center for Sleep and Wake Disorders — Chevy Chase, Maryland, United States
• Pullmonary Rehabilition Associates — Youngstown, Ohio, United States
• Berks Schuylkill Respiratory Specialists, Ltd. — Reading, Pennsylvania, United States
• Bogan Sleep Consultants, LLC — Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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