Status:
RECRUITING
The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea
Lead Sponsor:
Inspire Medical Systems, Inc.
Conditions:
Sleep Apnea, Obstructive
Eligibility:
All Genders
18+ years
Phase:
NA
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 a...
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
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05428839
Start Date
May 11 2022
End Date
January 31 2025
Last Update
October 17 2024
Active Locations (10)
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1
Valley ENT
Scottsdale, Arizona, United States, 85260
2
Rush University Medical Center
Chicago, Illinois, United States, 60612
3
Mason City Clinic
Mason City, Iowa, United States, 50401
4
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States, 02114