EURO-STIM: Long-term tracking of Inspire therapy for obstructive sleep apnea
Longitudinal Outcomes and Adherence of the Inspire System, EURO-STIM Registry
This registry will track people with obstructive sleep apnea who have an Inspire implant to see how they use the device over time and how well they stick with therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Inspire Medical Systems, Inc. Industry-sponsored |
| Locations | 21 sites (Klagenfurt and 20 other locations) |
| Trial ID | NCT06971796 on ClinicalTrials.gov |
What this trial studies
EURO-STIM is a longitudinal observational registry collecting real-world outcomes and device adherence data from patients treated with the Inspire upper airway stimulation system. Participants receive routine clinical care with no required study-specific interventions or extra testing, and data are captured during standard follow-up visits. The registry aims to document the life cycle of Inspire use, including therapy adherence, clinical outcomes, and device-related events across multiple European centers. Eligibility is limited to patients implanted with or receiving an Inspire device who can give informed consent and attend routine clinic visits.
Who should consider this trial
Good fit: Adults implanted with or scheduled to receive an Inspire upper airway stimulation device who can give informed consent and will attend routine clinic follow-up are ideal candidates.
Not a fit: People without an Inspire implant, those unlikely to survive a year, or patients unable to attend routine follow-up visits are unlikely to receive benefit from participating.
Why it matters
Potential benefit: If successful, the registry could improve understanding of long-term adherence and outcomes with Inspire, helping clinicians optimize patient selection and management.
How similar studies have performed: Prior controlled trials and registries of hypoglossal nerve stimulation, including earlier Inspire studies, have shown reductions in OSA severity and improved adherence, so this registry extends existing real-world evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Any patient implanted with or receiving an Inspire implant, who meets the following criteria, is eligible to participate in the registry: 1. Capable of giving informed consent, as required per institution 2. Willing to return for routine clinic visits as required for Inspire therapy management Exclusion Criteria: Any patient who meets any of the following criteria will not be eligible to participate in the registry: 1. Has a life expectancy of less than one year 2. Any reason the clinician deems patient is unfit for participation in the study
Where this trial is running
Klagenfurt and 20 other locations
- Klinikum Klagenfurt, KABEG — Klagenfurt, Austria (Not_yet_recruiting)
- Ordensklinikum Linz — Linz, Austria (Not_yet_recruiting)
- Universitair Ziekenhuis Antwerpen — Edegem, Belgium (Not_yet_recruiting)
- Angers University Hospital Center — Angers, France (Not_yet_recruiting)
- CHU Grenoble Alpes — La Tronche, France (Not_yet_recruiting)
- Clinique de la Louviere — Lille, France (Not_yet_recruiting)
- Hôpital d'Instruction des Armées Laveran — Marseille, France (Not_yet_recruiting)
- Clinique Beausoleil — Montpellier, France (Not_yet_recruiting)
- CHU Saint Etienne — Saint-Priest-en-Jarez, France (Not_yet_recruiting)
- Asklepios Klinik Hamburg — Hamburg, Germany (Recruiting)
- Universitatsklinikum Hamburg Eppendorf — Hamburg, Germany (Recruiting)
- Klinik für HNO-Heilkunde/HNO-Schlaflabor — Lübeck, Germany (Not_yet_recruiting)
- Otto-von-Guericke-Universität Magdeburg — Magdeburg, Germany (Not_yet_recruiting)
- Universitäts-HNO-Klinik Mannheim — Mannheim, Germany (Not_yet_recruiting)
- Klinikum Rechts der Isar Technische Universität München — Munich, Germany (Recruiting)
- Sint Lucas Andreas Ziekenhus (OLVG) — Amsterdam, Netherlands (Not_yet_recruiting)
- St. Antonius Ziekenhuis Nieuwegein — Nieuwegein, Netherlands (Not_yet_recruiting)
- Kantonnspital Baselland-Liestal — Liestal, Switzerland (Not_yet_recruiting)
- Guy's & St Thomas' NHS Foundation Trust — London, United Kingdom (Not_yet_recruiting)
- University College London Hospitals NHS Foundation Trust — London, United Kingdom (Not_yet_recruiting)
- Manchester University NHS Trust — Manchester, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Elyse Ebeling
- Email: elyseebeling@inspiresleep.com
- Phone: (763) 250-9432
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.