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Diagnostic Method for Obstructive Sleep Apnea (PREDICTOR Trial)

N/A

Recruiting

Research Sponsored by Inspire Medical Systems, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, prior to routine diagnostic drug induced sleep endoscopy

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a quick and non-invasive way to measure the width of a person's airway, which could help in diagnosing and treating obstructive sleep apnea.

Who is the study for?

This trial is for up to 300 people with obstructive sleep apnea who are being checked for airway surgery. They must meet the criteria for Inspire Upper Airway Stimulation and be undergoing a standard diagnostic procedure called drug-induced sleep endoscopy.

What is being tested?

The study is exploring if a quick, non-invasive mouth measurement can predict airway collapse in patients with obstructive sleep apnea. This additional test takes just 2-3 minutes during their regular evaluation for airway surgery.

What are the potential side effects?

Since the intervention involves only an extra measurement of the mouth's width, side effects are minimal to none. The main requirement is that participants must be able to lie on their back comfortably for a few minutes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, prior to routine diagnostic drug induced sleep endoscopy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, prior to routine diagnostic drug induced sleep endoscopy

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, prior to routine diagnostic drug induced sleep endoscopy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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