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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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

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.

Study details
    Sleep Apnea
    Obstructive

NCT05428839

Inspire Medical Systems, Inc.

21 March 2024

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