EURO-STIM Registry

NCT06971796 | Recruiting

• 1 other identifier: 2023-004
• Study Type: observational
• Target: 1,000
• Locations: 7 countries
• Sites: 21

Brief 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.

Conditions

Obstructive Sleep Apnea; Obstructive Sleep Apnea (OSA)

Keywords

Sleep Apnea; OSA; Inspire; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• Apnea Hypopnea Index (AHI)

  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)

  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 Outcomes (6)

• DISE VOTE Classification

  DISE VOTE Score will be collected, if available, at baseline.

• Functional Outcomes of Sleep Questionnaire (FOSQ-30)

  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)

  PET will be collected at follow-up visits after device activation, if available.

• Maintenance of Wakefulness Test (MWT)

  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

  Therapy use will be collected at follow-up visits after device activation, if available.

Interventions

Inspire UAS System DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Any patient implanted with or receiving an Inspire implant, who meets the following criteria, is eligible to participate in the registry:
• Capable of giving informed consent, as required per institution
• Willing to return for routine clinic visits as required for Inspire therapy management

You may not qualify if:

• Any patient who meets any of the following criteria will not be eligible to participate in the registry:
• Has a life expectancy of less than one year
• Any reason the clinician deems patient is unfit for participation in the study

Sponsors & Collaborators

• Inspire Medical Systems, Inc.: lead

Study Sites (21)

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

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Elyse Ebeling

CONTACT

(763) 250-9432; elyseebeling@inspiresleep.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: May 14, 2025
• Study Start: May 26, 2025
• Primary Completion (Estimated): April 1, 2035
• Study Completion (Estimated): April 1, 2035
• Last Updated: September 8, 2025

Record last verified: 2025-04

Locations

AU (2); CH (1); NL (2); BE (1); DE (6); FR (6); GB (3)