A Study to Determine Preferences Towards Interface Products

Study Overview
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Brief Summary
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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.

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

Conditions
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Sleep Disorder; Breathing-Related

Intervention / Treatment
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* Other: Standard of Care
* Other: Mask Advice Tool


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care<br> | Other: Standard of Care<br>* 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.<br>|
| Experimental: Mask Advice Tool<br> | Other: Mask Advice Tool<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep Apnea