Trial record 1 of 1 for:
predictor, jordan weiner | Obstructive Sleep Apnea | United States
The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea (PREDICTOR)
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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 |
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Recruitment Status :
Recruiting
First Posted : June 23, 2022
Last Update Posted : December 27, 2022
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Sponsor:
Inspire Medical Systems, Inc.
Information provided by (Responsible Party):
Inspire Medical Systems, Inc.
- Study Details
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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 |
| 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 Genetics related topics:
Obstructive 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 :
- 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
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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
| Contact: Anna N Bader | 763-290-1174 | annabader@inspiresleep.com | |
| Contact: Mike Swierzewski | michaelswierzewski@inspiresleep.com |
Locations
| 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.
| 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 |
| 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.:
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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 |