Status:
RECRUITING
Pediatric Post-Approval Registry
Lead Sponsor:
Inspire Medical Systems, Inc.
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18-21 years
Brief Summary
This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatmen...
Detailed Description
This registry is a prospective, multi-center, single-arm study of pediatric subjects (ages 18-21 years) who are undergoing implant of the Inspire Upper Airway Stimulation (UAS) System for the treatmen...
Eligibility Criteria
Inclusion
- Subject is between 18 and 21 years of age;
- Subject has a diagnosis of moderate to severe OSA (15 ≤ AHI ≤ 65) based on a recent sleep study;
- Subject has documented failure of, or intolerance to, positive airway pressure treatments, despite attempts to improve compliance;
- Subject is contraindicated for, or not effectively treated by, adenotonsillectomy;
- Subject has followed standard of care in considering all other alternative/adjunct therapies;
- Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to activate the stimulation;
- Subject is willing and able to return for follow-up visits, undergo sleep studies (including in-lab and at-home), and complete questionnaires related to the registry;
- Subject is willing and able to provide informed consent.
Exclusion
- Subject has a combination of central + mixed apneas \> 25% of the total apnea-hypopnea index (AHI);
- Subject has any anatomical finding that would compromise the performance of upper airway stimulation, such as the presence of complete concentric collapse of the soft palate;
- Subject has any condition or procedure that has compromised neurological control of the upper airway;
- Subject is unable, or does not have the necessary assistance, to operate the patient remote;
- Subject is pregnant or plans to become pregnant;
- Subject has an implantable device that may be susceptible to unintended interaction with the Inspire System;
- Subject has a terminal illness with life expectancy \< 12 months;
- Any other reason the investigator deems the subject is unfit for participation in the registry.
Key Trial Info
Start Date :
November 30 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04457154
Start Date
November 30 2021
End Date
April 1 2028
Last Update
February 25 2025
Active Locations (8)
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1
Childrens Hospital of Colorado
Aurora, Colorado, United States, 80045
2
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
3
Duke University
Durham, North Carolina, United States, 27705
4
Cincinnati Childrens Hospital
Cincinnati, Ohio, United States, 45229