The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea
Status unconfirmed · Not applicable
Conditions studied: Sleep Apnea, Obstructive
In brief
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.
Key facts
- Study ID
- NCT05428839
- Run by
- Inspire Medical Systems, Inc.
- People needed
- 300
- Starts
- 2022-05-11
- Expected to finish
- 2025-01-31
- Last updated by the study team
- 2024-10-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Valley ENT — Scottsdale, Arizona, United States (enrolling)
- Rush University Medical Center — Chicago, Illinois, United States (enrolling)
- Mason City Clinic — Mason City, Iowa, United States (enrolling)
- Massachusetts Eye and Ear Infirmary — Boston, Massachusetts, United States (enrolling)
- ENT Specialty Care of MN — Saint Louis Park, Minnesota, United States (enrolling)
- Ohio State University — Columbus, Ohio, United States (enrolling)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
- Thomas Jefferson University — Philadelphia, Pennsylvania, United States (enrolling)
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (enrolling)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
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