Pediatric Post-Approval Registry
Start Date
11/30/2021
Completion Date
4/1/2028
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 treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant.
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 treatment of moderate or severe obstructive sleep apnea (OSA). Implanted subjects will be followed for 5 years post-implant. Subjects will be recruited in accordance with the approved Inspire UAS indication for use and will only include those subjects who are within the new age indication (18-21 years of age). Implanted subjects must meet the registry eligibility criteria. Those subjects that are enrolled but fail to meet the eligibility criteria will be considered screen failures. This registry will collect safety and effectiveness data on 60 implanted subjects at a minimum of 5 qualified clinical centers in the United States. Study data will be collected at the following timepoints: Baseline (pre-implant) Implant Activation (1 month post-implant) 6 Months post-implant 1, 2, 3, 4, 5 years post-implant
Eligibility Criteria
Age Range: 18 years to 21 years
Interventions
Inspire Upper Airway Stimulation System
Conditions
Locations
Childrens Hospital of Colorado
Aurora, Colorado 80045
United States
Children's Healthcare of Atlanta
Atlanta, Georgia 30329
United States
Duke University
Durham, North Carolina 27705
United States
Cincinnati Childrens Hospital
Cincinnati, Ohio 45229
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19406
United States
Children's Hospital of Pittsburgh
Sewickley, Pennsylvania 15143
United States
University of Texas Southwestern/Children's Hospital of Dallas
Dallas, Texas 75207
United States
Children's Hospital of the King's Daughters/East Virginia Medical School
Norfolk, Virginia 23507
United States