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

Inspire Medical Systems

Status: Enrolling

Conditions: Sleep Apnea, Obstructive

Treatments: Diagnostic Test: Pharyngeal width measurement

Study type: Interventional

Funder types: Industry

Identifiers

NCT05428839

20021-003

Details and patient eligibility

About

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.

Full 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

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)