RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2022-05-11
Study Completion:2025-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05428839

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient meets the indications for the Inspire Upper Airway Stimulation
  2. * Patient is being evaluated by drug-induced sleep endoscopy as standard-of-care diagnostic for OSA surgery.
  1. * Patient is unable to lie supine for 2-3 minutes in order to undergo airway measurement
  2. * Any other reason the investigator deems that the patient is unfit for participation in the study.

Contacts and Locations

Study Contact

Anna N Bader
CONTACT
763-290-1174
annabader@inspiresleep.com
Mike Swierzewski
CONTACT
michaelswierzewski@inspiresleep.com

Study Locations (Sites)

Valley ENT
Scottsdale, Arizona, 85260
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
Mason City Clinic
Mason City, Iowa, 50401
United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
United States
ENT Specialty Care of MN
Saint Louis Park, Minnesota, 55404
United States
Ohio State University
Columbus, Ohio, 43121
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15219
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

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 Registration Dates

Study Start Date2022-05-11
Study Completion Date2025-01-31

Study Record Updates

Study Start Date2022-05-11
Study Completion Date2025-01-31

Terms related to this study

Keywords Provided by Researchers

  • OSA

Additional Relevant MeSH Terms

  • Sleep Apnea, Obstructive