Tracking Long-Term Outcomes and Use of the Inspire System in Patients with Obstructive Sleep Apnea

What this Trial Is About

Researchers are observing the long-term outcomes and adherence of the Inspire UAS System, a device used for patients with obstructive sleep apnea OSA. This observational registry aims to track the patients experience with the Inspire System through regular clinical care visits, capturing data throughout the patients use of the device. The study is sponsored by Inspire Medical Systems, Inc. and does not require any additional interventions or testing beyond routine care. Participants in this study will have the Inspire UAS System implanted, which includes three components an implantable pulse generator, a stimulation lead, and a sensing lead. Patients also receive a remote control to activate the therapy. The registry collects data during routine follow-up visits and does not involve experimental treatments or randomization. Throughout the study, participants will have clinical data collected such as the Apnea Hypopnea Index AHI, Epworth Sleepiness Scale ESS, and other sleep-related assessments if available from routine care. Researchers will monitor therapy use, patient experience, and any adverse events reported during implant and follow-up visits. The study will continue through April 2035, allowing long-term observation of the Inspire Systems use in everyday clinical settings.

EURO-STIM Registry