A Study to Determine Preferences Towards Interface Products

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-18

Study Completion Date

2020-02-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Sleep Disorder; Breathing-Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard of Care

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type OTHER

Participants will have a Positive Airway Pressure (PAP) mask chosen to wear for a period of 90 days as provided by the sites standard of care.

Mask Advice Tool

Group Type EXPERIMENTAL

Mask Advice Tool

Intervention Type OTHER

Participants will have a Positive Airway Pressure (PAP) mask chosen to wear for a period of 90 days as provided by the mask advice tool.

Interventions

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Standard of Care

Participants will have a Positive Airway Pressure (PAP) mask chosen to wear for a period of 90 days as provided by the sites standard of care.

Intervention Type OTHER

Mask Advice Tool

Participants will have a Positive Airway Pressure (PAP) mask chosen to wear for a period of 90 days as provided by the mask advice tool.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No