The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 300
- Locations
- 10
- Primary Endpoint
- 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
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
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
Time Frame: Baseline, prior to routine diagnostic drug induced sleep endoscopy
Pharyngeal width will be measured in millimeters using a caliper
Secondary Outcomes
No secondary outcomes reported