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.

Study Overview

• Status: Completed
• Conditions: Sleep Disorder; Breathing-Related
• Intervention / Treatment: Other: Standard of Care; Other: Mask Advice Tool

• Study Type: Interventional
• Enrollment (Actual): 310
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Kissimmee, Florida, United States, 34741
      • Pulmonary Disease Specialists, PA, d/b/a PDS Research
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Center For Sleep and Wake Disorders
  • Ohio
    • Youngstown, Ohio, United States, 44512
      • Pullmonary Rehabilition Associates
  • Pennsylvania
    • Reading, Pennsylvania, United States, 19610
      • Berks Schuylkill Respiratory Specialists, Ltd.
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Bogan Sleep Consultants, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care	Other: 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.
Experimental: Mask Advice Tool	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants requiring one or more mask re-fits	Proportion of participants in each arm requiring one or more mask re-fits.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of masks tried during the initial fitting visit	Number of masks tried during the initial fitting visit in each arm.	90 days
Number of masks tried after going home with the first mask	Number of masks tried after going home with the first mask in each arm.	90 days
Amount of time to fit each mask	Amount of time to fit each mask in each arm.	90 days
Number of sleep clinic or sleep center callbacks related to mask fitting issues	Number of sleep clinic or sleep center callbacks related to mask fitting issues in each arm.	90 days
The amount of time spent on these calls to resolve mask issues	The amount of time spent on these calls to resolve mask issues in each arm.	90 days
Number of unplanned visits to adjust current mask or fit with another masks	Number of unplanned visits to adjust current mask or fit with another masks in each arm.	90 days
Duration of the unplanned visits	Duration of the unplanned visits in each arm.	90 days
Adherence to CPAP therapy	Adherence to CPAP therapy as determined by average hours of use	90 days
Mask leak for chosen masks	Mask leak for chosen masks in each arm.	90 days
Subjective preference rated by patients	Patients will complete a "Post-Trial Questionnaire" to rate their post-trial experience, on a 0-10 scale. "0" meaning strongly disagree/unlikely, "10" meaning strongly agree/likely. A higher score means a better outcome.	90 days
Subjective preference rated by clinicians	Clinicians will complete a "Post-Trial Questionnaire" to rate their post-trial experience, on a 0-10 scale. "0" meaning strongly disagree/unlikely, "10" meaning strongly agree/likely. A higher score means a better outcome.	90 days

Collaborators and Investigators

• Sponsor: Philips Respironics

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2019
• Primary Completion (Actual): February 7, 2020
• Study Completion (Actual): February 7, 2020

Study Registration Dates

• First Submitted: May 8, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): July 7, 2020
• Last Update Submitted That Met QC Criteria: July 1, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Sleep Apnea
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders
• Other Study ID Numbers: SRC-SLE(PI)-CP-2018-10129

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No