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A Study to Determine Preferences Towards Interface Products

Primary Purpose

Sleep Disorder; Breathing-Related

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care
Mask Advice Tool
Sponsored by
Philips Respironics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sleep Disorder; Breathing-Related focused on measuring Sleep Apnea

Eligibility Criteria

21 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Pulmonary Disease Specialists, PA, d/b/a PDS Research
  • Center for Sleep and Wake Disorders
  • Pullmonary Rehabilition Associates
  • Berks Schuylkill Respiratory Specialists, Ltd.
  • Bogan Sleep Consultants, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

Mask Advice Tool

Arm Description

Outcomes

Primary Outcome Measures

Proportion of participants requiring one or more mask re-fits
Proportion of participants in each arm requiring one or more mask re-fits.

Secondary Outcome Measures

Number of masks tried during the initial fitting visit
Number of masks tried during the initial fitting visit in each arm.
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.
Amount of time to fit each mask
Amount of time to fit each mask in each arm.
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.
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.
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.
Duration of the unplanned visits
Duration of the unplanned visits in each arm.
Adherence to CPAP therapy
Adherence to CPAP therapy as determined by average hours of use
Mask leak for chosen masks
Mask leak for chosen masks in each arm.
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.
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.

Full Information

First Posted
May 8, 2019
Last Updated
July 1, 2020
Sponsor
Philips Respironics
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1. Study Identification

Unique Protocol Identification Number
NCT03948152
Brief Title
A Study to Determine Preferences Towards Interface Products
Official Title
A Study to Determine Clinician and Patient Preferences Towards Interface Products Recommended by the 3D Mask Advice Tool
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 18, 2019 (Actual)
Primary Completion Date
February 7, 2020 (Actual)
Study Completion Date
February 7, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Respironics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder; Breathing-Related
Keywords
Sleep Apnea

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Title
Mask Advice Tool
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
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
Intervention Name(s)
Mask Advice Tool
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of participants requiring one or more mask re-fits
Description
Proportion of participants in each arm requiring one or more mask re-fits.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Number of masks tried during the initial fitting visit
Description
Number of masks tried during the initial fitting visit in each arm.
Time Frame
90 days
Title
Number of masks tried after going home with the first mask
Description
Number of masks tried after going home with the first mask in each arm.
Time Frame
90 days
Title
Amount of time to fit each mask
Description
Amount of time to fit each mask in each arm.
Time Frame
90 days
Title
Number of sleep clinic or sleep center callbacks related to mask fitting issues
Description
Number of sleep clinic or sleep center callbacks related to mask fitting issues in each arm.
Time Frame
90 days
Title
The amount of time spent on these calls to resolve mask issues
Description
The amount of time spent on these calls to resolve mask issues in each arm.
Time Frame
90 days
Title
Number of unplanned visits to adjust current mask or fit with another masks
Description
Number of unplanned visits to adjust current mask or fit with another masks in each arm.
Time Frame
90 days
Title
Duration of the unplanned visits
Description
Duration of the unplanned visits in each arm.
Time Frame
90 days
Title
Adherence to CPAP therapy
Description
Adherence to CPAP therapy as determined by average hours of use
Time Frame
90 days
Title
Mask leak for chosen masks
Description
Mask leak for chosen masks in each arm.
Time Frame
90 days
Title
Subjective preference rated by patients
Description
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.
Time Frame
90 days
Title
Subjective preference rated by clinicians
Description
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.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Pulmonary Disease Specialists, PA, d/b/a PDS Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Center for Sleep and Wake Disorders
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Pullmonary Rehabilition Associates
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Facility Name
Berks Schuylkill Respiratory Specialists, Ltd.
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19610
Country
United States
Facility Name
Bogan Sleep Consultants, LLC
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study to Determine Preferences Towards Interface Products

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