Pediatric Down Syndrome Post-Approval Study
Inspire Medical Systems, Inc.
Summary
The purpose of this Post Approval research study is to assess ongoing safety and effectiveness of the Inspire therapy in adolescents and young adults (age 13-18) with Down syndrome and severe sleep apnea. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatric Down syndrome population.
Description
This is a multi-center, prospective, single-arm study conducted under a common implant and follow-up protocol. The objective will be to follow sixty (60) adolescents (13 - 18), with Down Syndrome and severe sleep apnea for 5-years after undergoing implant of the Inspire Upper Airway Stimulation (UAS) system. The objective of the study is to provide an ongoing safety and effectiveness assessment of the Inspire UAS System in the Pediatrics Down Syndrome population. Prior to implant subjects will be required to meet eligibility criteria that is based on an in-lab PSG, surgical consultation and d…
Eligibility
- Age range
- 13–18 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patient has been diagnosed with Down syndrome; 2. Patient is 13-18 years of age; 3. Patient has been diagnosed with severe obstructive sleep apnea, with an AHI of ≥ 10 and ≤ 50 based on a recent (within 6 months of enrollment) qualified in-lab sleep study (PSG); 4. Patient has documented failure of, or intolerance to, positive airway pressure therapies (such as CPAP or BiPAP) despite attempts to improve compliance; 5. Patient is contraindicated for, or not effectively treated by, adenotonsillectomy; 6. Treatment of patient's OSA has followed standard of care in consider…
Interventions
- DeviceHypoglossal Nerve Stimulation
Implant of Inspire Upper Airway Stimulation (UAS) system for treatment of obstructive sleep apnea (OSA) in the pediatric down syndrome population
Locations (6)
- Phoenix Children's HospitalPhoenix, Arizona
- Children's Hospital Orange CountyOrange, California
- University of South Florida Morsani College of MedicineTampa, Florida
- Northwell Cohen Children's HospitalQueens, New York
- Cleveland Clinic FoundationCleveland, Ohio
- Baylor College of Medicine/ Texas Children's HospitalHouston, Texas