CompletedNot Applicable

A Study to Determine Preferences Towards Interface Products

United States310 participantsStarted 2019-04-18

Plain-language summary

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.

Who can participate

Age range

21 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 peri…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of participants requiring one or more mask re-fits

Timeframe: 90 days

Trial details

NCT IDNCT03948152

SponsorPhilips Respironics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-02-07

View on ClinicalTrials.gov More Sleep Disorder; Breathing-Related trials