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

March 7, 2024 updated by: Inspire Medical Systems, Inc.
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Recruiting
        • Valley ENT
        • Contact:
        • Principal Investigator:
          • Jordan Weiner, MD
    • Illinois
    • Iowa
      • Mason City, Iowa, United States, 50401
        • Recruiting
        • Mason City Clinic
        • Contact:
        • Principal Investigator:
          • Dnaiel Lee, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55404
        • Recruiting
        • ENT Specialty Care of MN
        • Principal Investigator:
          • Ilya Perepelitsyn, MD
        • Contact:
    • Ohio
      • Columbus, Ohio, United States, 43121
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Principal Investigator:
          • Colin Huntley, MD
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15219
        • Recruiting
        • University of Pittsburgh Medical Center
        • Contact:
        • Principal Investigator:
          • Ryan Soose, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Principal Investigator:
          • David Kent, MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Baseline, prior to routine diagnostic drug induced sleep endoscopy
Pharyngeal width will be measured in millimeters using a caliper
Baseline, prior to routine diagnostic drug induced sleep endoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inspire Medical Systems, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2022

Primary Completion (Actual)

January 11, 2024

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

May 10, 2022

First Submitted That Met QC Criteria

June 17, 2022

First Posted (Actual)

June 23, 2022

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20021-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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