A Study to Determine Preferences Towards Interface Products

NCT03948152 | Completed

• 1 other identifier: SRC-SLE(PI)-CP-2018-10129
• Study Type: interventional
• Target: 310
• Locations: 1 country
• Sites: 5

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.

Conditions

Sleep Disorder; Breathing-Related

Keywords

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 (11)

• Number of masks tried during the initial fitting visit

  90 days

• Number of masks tried after going home with the first mask

  90 days

• Amount of time to fit each mask

  90 days

• Number of sleep clinic or sleep center callbacks related to mask fitting issues

  90 days

• The amount of time spent on these calls to resolve mask issues

  90 days

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

Other: Standard of Care

Mask Advice Tool

EXPERIMENTAL

Other: Mask Advice Tool

Interventions

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

Mask Advice Tool 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.

Mask Advice Tool

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Respironics: lead

Study Sites (5)

Pulmonary Disease Specialists, PA, d/b/a PDS Research

Kissimmee, Florida, 34741, United States

Location

Center for Sleep and Wake Disorders

Chevy Chase, Maryland, 20815, United States

Location

Pullmonary Rehabilition Associates

Youngstown, Ohio, 44512, United States

Location

Berks Schuylkill Respiratory Specialists, Ltd.

Reading, Pennsylvania, 19610, United States

Location

Bogan Sleep Consultants, LLC

Columbia, South Carolina, 29201, United States

Location

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Apnea Syndromes

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 13, 2019
• Study Start: April 18, 2019
• Primary Completion: February 7, 2020
• Study Completion: February 7, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)