A Study to Determine Preferences Towards Interface Products | NCT03948152

Studies
A Study to Determine Preferences Towards Interface Products

NCT03948152

Sponsor

Philips Respironics

Status

Completed

Last Update Posted

Jul 7, 2020Actual

Enrollment

310Actual

Phase

Not Applicable

Conditions

Sleep Disorder; Breathing-Related

Interventions

Standard of Care
Mask Advice Tool

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 18, 2019Actual

Primary Completion Date

Feb 7, 2020Actual

Completion Date

Feb 7, 2020Actual

First Submitted Date

May 8, 2019

First Submission Date that Met QC Criteria

May 10, 2019

First Posted Date

May 13, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 1, 2020

Last Update Posted Date

Jul 7, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

310Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Standard of Care	Active Comparator		Other: Standard of Care
Mask Advice Tool	Experimental		Other: Mask Advice Tool

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard of Care	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.	Standard of Care

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Pulmonary Disease Specialists, PA, d/b/a PDS Research		Kissimmee	Florida	34741	United States
Center for Sleep and Wake Disorders

ID	Term
D012893	Sleep Wake Disorders
D012891	Sleep Apnea Syndromes

ID	Term
D009422	Nervous System Diseases
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation