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Treatment 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

PREDICTOR Trial 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.Check my eligibility

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.See study design

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.

PREDICTOR Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Inspire Medical Systems, Inc.Lead Sponsor

11 Previous Clinical Trials

6,387 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are enrolled in this research effort?

"This research requires 300 volunteers, who meet the eligibility requirements, to partake in this trial. Ohio State University located in Columbus and University of Pennsylvania based in Philadelphia are two potential locations for enrolment."

Answered by AI

Are there still opportunities for volunteers to join this research?

"Data available on clinicaltrials.gov reveals that the current recruitment process for this medical trial began May 11th 2022 and was last refreshed November 29th 2022."

Answered by AI

How many healthcare centers are currently conducting this trial?

"As part of this clinical trial, patients can be accepted in various locations such as Ohio State University (Columbus, Ohio), the University of Pennsylvania (Philadelphia, Pennsylvania) and the University of Pittsburgh Medical Center (Pittsburgh, Iowa). Additionally there are 8 other sites."

Answered by AI