Actively Recruiting
Pediatric Post-Approval Registry
Led by Inspire Medical Systems, Inc. · Updated on 2025-02-25
60
Participants Needed
8
Research Sites
330 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.
CONDITIONS
Official Title
Pediatric Post-Approval Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 considering all other alternative or 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
You will not qualify if you...
- Subject has a combination of central plus mixed apneas greater than 25% of the total apnea-hypopnea index (AHI)
- Subject has any anatomical finding that would compromise the performance of upper airway stimulation, such as 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 necessary assistance to operate the patient remote
- Subject is pregnant or plans to become pregnant
- Subject has an implantable device that may interact with the Inspire System
- Subject has a terminal illness with life expectancy less than 12 months
- Any other reason the investigator deems the subject unfit for participation in the registry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
Childrens Hospital of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
2
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
Terminated
3
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
4
Cincinnati Childrens Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
5
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19406
Actively Recruiting
6
Children's Hospital of Pittsburgh
Sewickley, Pennsylvania, United States, 15143
Actively Recruiting
7
University of Texas Southwestern/Children's Hospital of Dallas
Dallas, Texas, United States, 75207
Actively Recruiting
8
Children's Hospital of the King's Daughters/East Virginia Medical School
Norfolk, Virginia, United States, 23507
Actively Recruiting
Research Team
G
Gwen Gimmestad
CONTACT
M
Mike Swierzewski, MS
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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