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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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
        • Universitatsklinikum 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2035

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2035

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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