Inspire Pediatric Post-Approval Registry
Inspire Medical Systems, Inc.
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.
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 enrolle…
Eligibility
- Age range
- 18–21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Subject is between 18 and 21 years of age; 2. Subject has a diagnosis of moderate to severe OSA (15 ≤ AHI ≤ 65) based on a recent sleep study; 3. Subject has documented failure of, or intolerance to, positive airway pressure treatments, despite attempts to improve compliance; 4. Subject is contraindicated for, or not effectively treated by, adenotonsillectomy; 5. Subject has followed standard of care in considering all other alternative/adjunct therapies; 6. Subject is willing and able to have stimulation hardware permanently implanted and to use the patient remote to a…
Interventions
- DeviceInspire Upper Airway Stimulation System
Implant of the Inspire Upper Airway Stimulation System
Locations (8)
- Childrens Hospital of ColoradoAurora, Colorado
- Children's Healthcare of AtlantaAtlanta, Georgia
- Duke UniversityDurham, North Carolina
- Cincinnati Childrens HospitalCincinnati, Ohio
- Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania
- Children's Hospital of PittsburghSewickley, Pennsylvania