A Study to Determine Preferences Towards Interface Products

Sleep Disorder; Breathing-Related Clinical Trial

Official title:

A Study to Determine Clinician and Patient Preferences Towards Interface Products Recommended by the 3D Mask Advice Tool

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03948152
• Other study ID #: SRC-SLE(PI)-CP-2018-10129
• Status: Completed
• Phase: N/A
• Start date: April 18, 2019
• Est. completion date: February 7, 2020

Study information

• Verified date: July 2020
• Source: Philips Respironics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: February 7, 2020
• Est. primary completion date: February 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Disorder; Breathing-Related
• Sleep Wake Disorders

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Center for Sleep and Wake Disorders	Chevy Chase	Maryland
United States	Bogan Sleep Consultants, LLC	Columbia	South Carolina
United States	Pulmonary Disease Specialists, PA, d/b/a PDS Research	Kissimmee	Florida
United States	Berks Schuylkill Respiratory Specialists, Ltd.	Reading	Pennsylvania
United States	Pullmonary Rehabilition Associates	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Philips Respironics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of masks tried during the initial fitting visit	Number of masks tried during the initial fitting visit in each arm.	90 days
Secondary	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
Secondary	Amount of time to fit each mask	Amount of time to fit each mask in each arm.	90 days
Secondary	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
Secondary	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
Secondary	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
Secondary	Duration of the unplanned visits	Duration of the unplanned visits in each arm.	90 days
Secondary	Adherence to CPAP therapy	Adherence to CPAP therapy as determined by average hours of use	90 days
Secondary	Mask leak for chosen masks	Mask leak for chosen masks in each arm.	90 days
Secondary	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
Secondary	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