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Trial record 1 of 1 for:    predictor, jordan weiner | Obstructive Sleep Apnea | United States
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The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea (PREDICTOR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05428839
Recruitment Status : Recruiting
First Posted : June 23, 2022
Last Update Posted : December 27, 2022
Sponsor:
Information provided by (Responsible Party):
Inspire Medical Systems, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Sleep Apnea, Obstructive Diagnostic Test: Pharyngeal width measurement Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea
Actual Study Start Date : May 11, 2022
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock Sleep Apnea


Intervention Details:
  • Diagnostic Test: Pharyngeal width measurement
    A simple, non-invasive measurement of the pharyngeal width inside each subjects mouth


Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05428839


Contacts
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Contact: Anna N Bader 763-290-1174 annabader@inspiresleep.com
Contact: Mike Swierzewski michaelswierzewski@inspiresleep.com

Locations
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United States, Arizona
Valley ENT Recruiting
Scottsdale, Arizona, United States, 85260
Contact: Dr. Jordan Weiner       jweiner121@azvent.com   
Principal Investigator: Jordan Weiner, MD         
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Lauren Kret       lauren_n_kret@rush.edu   
Contact: Mahendra Shah       mahendrakumar_Shah@rush.edu   
Principal Investigator: Michael Hutz, MD         
United States, Iowa
Mason City Clinic Recruiting
Mason City, Iowa, United States, 50401
Contact: Leisel Magg       LMagg@mcclinic.com   
Principal Investigator: Dnaiel Lee, MD         
United States, Massachusetts
Massachusetts Eye and Ear Infirmary Recruiting
Boston, Massachusetts, United States, 02114
Contact: Brendan McBrine       Brendan_McBrine@MEEI.HARVARD.EDU   
Principal Investigator: Phillip Huyett, MD         
United States, Minnesota
ENT Specialty Care of MN Recruiting
Saint Louis Park, Minnesota, United States, 55404
Contact: Dr. Ilya Perepelitsyn, MD    612-871-1144      
Principal Investigator: Ilya Perepelitsyn, MD         
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43121
Contact: Beth Miles-Markley       beth.miles-markley@osumc.edu   
Principal Investigator: Eugene Chio, MD         
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Everett Seay       Everett.Seay@Pennmedicine.upenn.edu   
Principal Investigator: Raj Dedhia, MD         
Thomas Jefferson University Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Sruti Tekumalla       Sruti.Tekumalla@jefferson.edu   
Principal Investigator: Colin Huntley, MD         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15219
Contact: Tina Harrison       harrisonta@upmc.edu   
Principal Investigator: Ryan Soose, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Katherine Hartley       katherine.e.hartley@vumc.org   
Principal Investigator: David Kent, MD         
Sponsors and Collaborators
Inspire Medical Systems, Inc.
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Responsible Party: Inspire Medical Systems, Inc.
ClinicalTrials.gov Identifier: NCT05428839    
Other Study ID Numbers: 20021-003
First Posted: June 23, 2022    Key Record Dates
Last Update Posted: December 27, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Inspire Medical Systems, Inc.:
OSA
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases