NCT05428839

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Inspire Medical Systems, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Sleep Apnea, Obstructive

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Pharyngeal width measurement	A simple, non-invasive measurement of the pharyngeal width inside each subjects mouth

Timeline

• Start date: 2022-05-11
• Primary completion: 2024-01-11
• Completion: 2025-01-31
• First posted: 2022-06-23
• Last updated: 2024-10-17

Locations

10 sites across 1 country: United States