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

• Sponsor: Inspire Medical Systems, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05428839
• Collaborator: (none)
• Enrollment: 300
• Locations: 3
• Anticipated Duration (Months): 7.7
• Patients Per Site: 100
• Patients Per Site Per Month: 13.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea, Obstructive	Diagnostic Test: Pharyngeal width measurement	N/A

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 Design

• Study Type: Interventional
• Anticipated 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
• Anticipated Primary Completion Date: Dec 30, 2022
• Anticipated Study Completion Date: Dec 30, 2022

Outcome Measures

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 [Baseline, prior to routine diagnostic drug induced sleep endoscopy]

   Pharyngeal width will be measured in millimeters using a caliper

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Valley ENT	Scottsdale	Arizona	United States	85260
2	Rush University Medical Center	Chicago	Illinois	United States	60612
3	ENT Specialty Care of MN	Saint Louis Park	Minnesota	United States	55404

Sponsors and Collaborators

• Inspire Medical Systems, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Inspire Medical Systems, Inc.
• ClinicalTrials.gov Identifier: NCT05428839
• Other Study ID Numbers: 20021-003
• First Posted: Jun 23, 2022
• Last Update Posted: Jun 23, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• 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.: OSA
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Study Results

No Results Posted as of Jun 23, 2022