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

Description

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.

Conditions

Sleep Apnea, Obstructive

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Study Overview

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Study Details

Study 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.

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

Condition
Sleep Apnea, Obstructive
Intervention / Treatment

-

Contacts and Locations

Scottsdale

Valley ENT, Scottsdale, Arizona, United States, 85260

Chicago

Rush University Medical Center, Chicago, Illinois, United States, 60612

Mason City

Mason City Clinic, Mason City, Iowa, United States, 50401

Boston

Massachusetts Eye and Ear Infirmary, Boston, Massachusetts, United States, 02114

Saint Louis Park

ENT Specialty Care of MN, Saint Louis Park, Minnesota, United States, 55404

Columbus

Ohio State University, Columbus, Ohio, United States, 43121

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Philadelphia

Thomas Jefferson University, Philadelphia, Pennsylvania, United States, 19107

Pittsburgh

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States, 15219

Nashville

Vanderbilt University Medical Center, Nashville, Tennessee, United States, 37232

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Inspire Medical Systems, Inc.,

Study Record Dates

2025-01-31