EURO-STIM Registry

Condition(s) studied

Investigational drug(s) / intervention(s)

Inspire UAS System: Participants will be implanted with the Inspire UAS System, which is a permanent, implantable therapy that consists of three implantable components: an IPG, a stimulation lead, and a sensing lead. In addition, the study subject receives a remote control to activate the therapy.

Study summary

The registry is to measure longitudinal outcomes and adherence of the Inspire System. The goal of the registry is to capture the life cycle of the patient's use of the Inspire System through routine clinical care visits. There are no required interventions or testing.

Eligibility

Primary outcome measure(s)

• Apnea Hypopnea Index (AHI) — Total AHI, supine and non-supine AHI, documented as events/hour of sleep will be collected at baseline, prior to implant, and at follow-up visits, if available, as determined by clinical standard of care.
  The AHI, or number of apnea and hypopnea events per hour, is a measure of OSA severity.
• Epworth Sleepiness Scale (ESS) — ESS will be collected at baseline and follow-up visits, if available, as determined by clinical standard of care.
  The ESS is a validated, self-report instrument that rates a subject's tendency to fall asleep in eight common daily situations13. The ESS has been validated primarily in OSA.

Trial sites (21)