The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea
PREDICTOR
1 other identifier
interventional
300
1 country
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
Typical duration for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2022
CompletedStudy Start
First participant enrolled
May 11, 2022
CompletedFirst Posted
Study publicly available on registry
June 23, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2025
CompletedOctober 17, 2024
March 1, 2024
1.7 years
May 10, 2022
October 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Pharyngeal width will be measured in millimeters using a caliper
Baseline, prior to routine diagnostic drug induced sleep endoscopy
Interventions
A simple, non-invasive measurement of the pharyngeal width inside each subjects mouth
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Valley ENT
Scottsdale, Arizona, 85260, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Mason City Clinic
Mason City, Iowa, 50401, United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114, United States
ENT Specialty Care of MN
Saint Louis Park, Minnesota, 55404, United States
Ohio State University
Columbus, Ohio, 43121, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2022
First Posted
June 23, 2022
Study Start
May 11, 2022
Primary Completion
January 11, 2024
Study Completion
January 31, 2025
Last Updated
October 17, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share