The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea
- Conditions
- Sleep Apnea, Obstructive
- Registration Number
- NCT05428839
- Lead Sponsor
- Inspire Medical Systems, Inc.
- Brief Summary
This study is an exploratory, multicenter study of up to 300 subjects diagnosed with obstructive sleep apnea who are being evaluated for airway surgery. Subjects will undergo standard evaluation for airway surgery as part of standard of care. In addition to the standard airway assessment, a simple, non-invasive measurement of the width of the inside of each subjects mouth will be performed. This measurement takes 2-3 minutes to perform.
- Detailed Description
The objective of the study is to determine whether pharyngeal width (inside of the mouth) is an appropriate measurement to predict absence of complete concentric collapse (CCC) at the soft palate
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Patient meets the indications for the Inspire Upper Airway Stimulation
- Patient is being evaluated by drug-induced sleep endoscopy as standard-of-care diagnostic for OSA surgery.
- Patient is unable to lie supine for 2-3 minutes in order to undergo airway measurement
- Any other reason the investigator deems that the patient is unfit for participation in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Measurement of pharyngeal width to determine if there is correlation between pharyngeal width and presence or absence of complete concentric collapse at the soft palate during drug induced sleep endoscopy Baseline, prior to routine diagnostic drug induced sleep endoscopy Pharyngeal width will be measured in millimeters using a caliper
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Valley ENT
🇺🇸Scottsdale, Arizona, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Mason City Clinic
🇺🇸Mason City, Iowa, United States
Massachusetts Eye and Ear Infirmary
🇺🇸Boston, Massachusetts, United States
ENT Specialty Care of MN
🇺🇸Saint Louis Park, Minnesota, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States