The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea

Sleep Apnea, Obstructive Clinical Trial

— PREDICTOR  

Official title:

The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05428839
• Other study ID #: 20021-003
• Status: Recruiting
• Phase: N/A
• Start date: May 11, 2022
• Est. completion date: January 31, 2025

Study information

• Verified date: March 2024
• Source: Inspire Medical Systems, Inc.
• Contact: Anna N Bader
• Phone: 763-290-1174
• Email: annabader[@]inspiresleep.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 31, 2025
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• Pharyngeal width measurement
A simple, non-invasive measurement of the pharyngeal width inside each subjects mouth

Locations

Country	Name	City	State
United States	Massachusetts Eye and Ear Infirmary	Boston	Massachusetts
United States	Rush University Medical Center	Chicago	Illinois
United States	Ohio State University	Columbus	Ohio
United States	Mason City Clinic	Mason City	Iowa
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	ENT Specialty Care of MN	Saint Louis Park	Minnesota
United States	Valley ENT	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Inspire Medical Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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