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

Primary Purpose

Sleep Apnea, Obstructive

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pharyngeal width measurement
Sponsored by
Inspire Medical Systems, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sleep Apnea, Obstructive focused on measuring OSA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Valley ENTRecruiting
  • Rush University Medical CenterRecruiting
  • Mason City ClinicRecruiting
  • Massachusetts Eye and Ear InfirmaryRecruiting
  • ENT Specialty Care of MNRecruiting
  • Ohio State UniversityRecruiting
  • University of PennsylvaniaRecruiting
  • Thomas Jefferson UniversityRecruiting
  • University of Pittsburgh Medical CenterRecruiting
  • Vanderbilt University Medical CenterRecruiting

Outcomes

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
Pharyngeal width will be measured in millimeters using a caliper

Secondary Outcome Measures

Full Information

First Posted
May 10, 2022
Last Updated
June 16, 2023
Sponsor
Inspire Medical Systems, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05428839
Brief Title
The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea
Acronym
PREDICTOR
Official Title
The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Inspire Medical Systems, Inc.

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive
Keywords
OSA

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
Pharyngeal width measurement
Intervention Description
A simple, non-invasive measurement of the pharyngeal width inside each subjects mouth
Primary Outcome Measure Information:
Title
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
Description
Pharyngeal width will be measured in millimeters using a caliper
Time Frame
Baseline, prior to routine diagnostic drug induced sleep endoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anna N Bader
Phone
763-290-1174
Email
annabader@inspiresleep.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mike Swierzewski
Email
michaelswierzewski@inspiresleep.com
Facility Information:
Facility Name
Valley ENT
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Jordan Weiner
Email
jweiner121@azvent.com
First Name & Middle Initial & Last Name & Degree
Jordan Weiner, MD
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lauren Kret
Email
lauren_n_kret@rush.edu
First Name & Middle Initial & Last Name & Degree
Mahendra Shah
Email
mahendrakumar_Shah@rush.edu
First Name & Middle Initial & Last Name & Degree
Michael Hutz, MD
Facility Name
Mason City Clinic
City
Mason City
State/Province
Iowa
ZIP/Postal Code
50401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Leisel Magg
Email
LMagg@mcclinic.com
First Name & Middle Initial & Last Name & Degree
Dnaiel Lee, MD
Facility Name
Massachusetts Eye and Ear Infirmary
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brendan McBrine
Email
Brendan_McBrine@MEEI.HARVARD.EDU
First Name & Middle Initial & Last Name & Degree
Phillip Huyett, MD
Facility Name
ENT Specialty Care of MN
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenniffer Hansen
Email
JHansen@entsc.com
First Name & Middle Initial & Last Name & Degree
Ilya Perepelitsyn, MD
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Miles-Markley
Email
beth.miles-markley@osumc.edu
First Name & Middle Initial & Last Name & Degree
Eugene Chio, MD
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Everett Seay
Email
Everett.Seay@Pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Raj Dedhia, MD
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sruti Tekumalla
Email
Sruti.Tekumalla@jefferson.edu
First Name & Middle Initial & Last Name & Degree
Colin Huntley, MD
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Harrison
Email
harrisonta@upmc.edu
First Name & Middle Initial & Last Name & Degree
Ryan Soose, MD
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Hartley
Email
katherine.e.hartley@vumc.org
First Name & Middle Initial & Last Name & Degree
David Kent, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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