A Study to Determine Preferences Towards Interface Products
- Conditions
- Sleep Disorder; Breathing-Related
- Interventions
- Other: Mask Advice ToolOther: Standard of Care
- Registration Number
- NCT03948152
- Lead Sponsor
- Philips Respironics
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 310
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mask Advice Tool Mask Advice Tool - Standard of Care Standard of Care -
- Primary Outcome Measures
Name Time Method Proportion of participants requiring one or more mask re-fits 90 days Proportion of participants in each arm requiring one or more mask re-fits.
- Secondary Outcome Measures
Name Time Method The amount of time spent on these calls to resolve mask issues 90 days 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 90 days Number of unplanned visits to adjust current mask or fit with another masks in each arm.
Number of sleep clinic or sleep center callbacks related to mask fitting issues 90 days Number of sleep clinic or sleep center callbacks related to mask fitting issues in each arm.
Number of masks tried during the initial fitting visit 90 days Number of masks tried during the initial fitting visit in each arm.
Amount of time to fit each mask 90 days Amount of time to fit each mask in each arm.
Duration of the unplanned visits 90 days Duration of the unplanned visits in each arm.
Adherence to CPAP therapy 90 days Adherence to CPAP therapy as determined by average hours of use
Number of masks tried after going home with the first mask 90 days Number of masks tried after going home with the first mask in each arm.
Mask leak for chosen masks 90 days Mask leak for chosen masks in each arm.
Subjective preference rated by patients 90 days 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 90 days 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.
Trial Locations
- Locations (5)
Center for Sleep and Wake Disorders
🇺🇸Chevy Chase, Maryland, United States
Berks Schuylkill Respiratory Specialists, Ltd.
🇺🇸Reading, Pennsylvania, United States
Pulmonary Disease Specialists, PA, d/b/a PDS Research
🇺🇸Kissimmee, Florida, United States
Pullmonary Rehabilition Associates
🇺🇸Youngstown, Ohio, United States
Bogan Sleep Consultants, LLC
🇺🇸Columbia, South Carolina, United States