Study of the Inspire Upper Airway Stimulation System Implant in Young Adults Aged 18 to 21 with Moderate to Severe Obstructive Sleep Apnea Five-Year Follow-Up Registry to Evaluate Safety and Effectiveness

What this Trial Is About

The trial investigates pediatric patients aged 18 to 21 years diagnosed with moderate to severe obstructive sleep apnea OSA. It evaluates the use of the Inspire Upper Airway Stimulation UAS System implant as a treatment option. This prospective, multi-center, single-arm registry study aims to collect data on safety and effectiveness after the device implantation, following participants for up to 5 years post-implant. Participants will receive the Inspire UAS System implant targeted at managing OSA symptoms. The study includes one group of pediatric subjects meeting the approved device indication and eligibility criteria. Data collection occurs at baseline before implantation, at implant activation one month post-implant, then at 6 months, and annually up to 5 years after implant. During the study, participants will attend scheduled visits for sleep studies, questionnaires, and device assessments to monitor safety and treatment effects. Researchers will evaluate device-related adverse events, changes in apnea hypopnea index AHI, oxygen desaturation index ODI, total sleep time with low oxygen saturation T90, and daytime sleepiness using the Epworth Sleepiness Scale ESS. Ongoing follow-up ensures comprehensive safety and effectiveness data over the full 5-year period.

Pediatric Post-Approval Registry