EURO-STIM Registry (EURO-STIM)

September 2, 2025 updated by: Inspire Medical Systems, Inc.

Longitudinal Outcomes and Adherence of the Inspire System, EURO-STIM Registry

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Klagenfurt, Austria
        • Not yet recruiting
        • Klinikum Klagenfurt, KABEG
        • Contact:
        • Principal Investigator:
          • Dr. Andreas Bischof
        • Principal Investigator:
          • Dr. Hanna Obermeier
      • Linz, Austria
  • Belgium
      • Edegem, Belgium
        • Not yet recruiting
        • Universitair Ziekenhuis Antwerpen
        • Contact:
        • Principal Investigator:
          • Prof. Dr. Olivier Vanderveken
  • France
      • Angers, France
        • Not yet recruiting
        • Angers University Hospital Center
        • Contact:
        • Principal Investigator:
          • Prof. Frédéric Gagnadoux
      • La Tronche, France
        • Not yet recruiting
        • CHU Grenoble Alpes
        • Contact:
        • Principal Investigator:
          • Prof. Renaud Tamisier
      • Lille, France
        • Not yet recruiting
        • Clinique de la Louvière
        • Contact:
        • Principal Investigator:
          • Dr. Sarah Boulanger
        • Principal Investigator:
          • Dr. Thibaut Gentina
      • Marseille, France
        • Not yet recruiting
        • Hôpital d'Instruction des Armées Laveran
        • Contact:
          • Dr. Stanislas Ballivet de Regloix
        • Principal Investigator:
          • Dr. Allali Laure
      • Montpellier, France
      • Saint-Priest-en-Jarez, France
  • Germany
      • Hamburg, Germany
        • Recruiting
        • Universitätsklinikum Hamburg Eppendorf
        • Contact:
        • Principal Investigator:
          • Prof. Dr. med Arne Boettcher
      • Hamburg, Germany
        • Recruiting
        • Asklepios Klinik Hamburg
        • Contact:
        • Principal Investigator:
          • Prof. Dr. med Thomas Verse
      • Lübeck, Germany
        • Not yet recruiting
        • Klinik für HNO-Heilkunde/HNO-Schlaflabor
        • Contact:
        • Principal Investigator:
          • Dr. med. Armin Steffen
      • Magdeburg, Germany
        • Not yet recruiting
        • Otto-von-Guericke-Universität Magdeburg
        • Contact:
        • Principal Investigator:
          • Dr.Stephanie Kühne
        • Principal Investigator:
          • Dr.Anja Giers
      • Mannheim, Germany
        • Not yet recruiting
        • Universitäts-HNO-Klinik Mannheim
        • Contact:
        • Principal Investigator:
          • Dr. Joachim T Maurer
      • Munich, Germany
        • Recruiting
        • Klinikum rechts der Isar Technische Universität München
        • Contact:
        • Principal Investigator:
          • Dr. Daniel Jira
  • Netherlands
      • Amsterdam, Netherlands
        • Not yet recruiting
        • Sint Lucas Andreas Ziekenhus (OLVG)
        • Contact:
        • Principal Investigator:
          • Dr. Peter van Maanen
      • Nieuwegein, Netherlands
        • Not yet recruiting
        • St. Antonius Ziekenhuis Nieuwegein
        • Contact:
        • Principal Investigator:
          • Dr. Marcel Copper
  • Switzerland
      • Liestal, Switzerland
        • Not yet recruiting
        • Kantonnspital Baselland-Liestal
        • Contact:
        • Principal Investigator:
          • Prof. Dr. Kurt Tschopp
  • United Kingdom
      • London, United Kingdom
        • Not yet recruiting
        • University College London Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Ryan Chin Taw Cheong
        • Principal Investigator:
          • Sara McNeillis
      • London, United Kingdom
        • Not yet recruiting
        • Guy's & St Thomas' NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Prof. Joerg Steier
        • Principal Investigator:
          • Yakubu Karagama
      • Manchester, United Kingdom
        • Not yet recruiting
        • Manchester University NHS Trust
        • Contact:
        • Principal Investigator:
          • Sadie Khwaja

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients previously implanted or scheduled to be implanted with an Inspire System will be informed of the registry and given the option to participate by qualified Euro-Stim Registry staff. Up to 1,000 patients at up to 55 centers in multiple countries in the European Union and the United Kingdom will be included in the registry.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Apnea Hypopnea Index (AHI)
Time Frame: 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.
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.
Epworth Sleepiness Scale (ESS)
Time Frame: 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.
ESS will be collected at baseline and follow-up visits, if available, as determined by clinical standard of care.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DISE VOTE Classification
Time Frame: DISE VOTE Score will be collected, if available, at baseline.
A Drug-Induced Sleep Endoscopy (DISE) is a diagnostic, standard of care procedure performed as part of the evaluation for airway surgeries (including implant of the Inspire System). The DISE is utilized to visualize the patient's airway obstruction.
DISE VOTE Score will be collected, if available, at baseline.
Functional Outcomes of Sleep Questionnaire (FOSQ-30)
Time Frame: FOSQ-30 will be collected at baseline and follow-up visits, if available and only if already collected as part of routine clinical care.
The FOSQ-30 is a validated, quality of life measurement that assesses the effect of a subject's daytime sleepiness on activities of ordinary living. It is commonly used in the clinical evaluation and management of OSA.
FOSQ-30 will be collected at baseline and follow-up visits, if available and only if already collected as part of routine clinical care.
Patient Experience with Therapy (PET)
Time Frame: PET will be collected at follow-up visits after device activation, if available.
The PET is a survey designed to collect information about patient's experience with the Inspire therapy.
PET will be collected at follow-up visits after device activation, if available.
Maintenance of Wakefulness Test (MWT)
Time Frame: Sleep latency is recorded in minutes and may be collected from a maintenance of wakefulness test performed at baseline and follow-up visits after device activation, if available.
The maintenance of wakefulness test is used to measure a person's ability to stay awake during a defined period of time.
Sleep latency is recorded in minutes and may be collected from a maintenance of wakefulness test performed at baseline and follow-up visits after device activation, if available.
Therapy Use
Time Frame: Therapy use will be collected at follow-up visits after device activation, if available.
Therapy use, reported as hours of use per week, is recorded during follow-up visits and will be collected from the Inspire physician programmer.
Therapy use will be collected at follow-up visits after device activation, if available.
Adverse Events
Time Frame: The number of events (as well as the % of subjects in which the event occurred) will be reported at implant and at follow-up timepoints.
Both serious and non-serious procedure-related and device/therapy related adverse events will be collected and reported.
The number of events (as well as the % of subjects in which the event occurred) will be reported at implant and at follow-up timepoints.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inspire Medical Systems, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2025

Primary Completion (Estimated)

April 1, 2035

Study Completion (Estimated)

April 1, 2035

Study Registration Dates

First Submitted

April 7, 2025

First Submitted That Met QC Criteria

May 7, 2025

First Posted (Actual)

May 14, 2025

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-004

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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