EURO-STIM Registry

NCT ID: NCT06971796

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-26

Study Completion Date

2035-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea Obstructive Sleep Apnea (OSA)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Inspire Medical Systems, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Klinikum Klagenfurt, KABEG

Klagenfurt, , Austria

Site Status NOT_YET_RECRUITING

Ordensklinikum Linz

Linz, , Austria

Site Status NOT_YET_RECRUITING

Universitair Ziekenhuis Antwerpen

Edegem, , Belgium

Site Status NOT_YET_RECRUITING

Angers University Hospital Center

Angers, , France

Site Status NOT_YET_RECRUITING

CHU Grenoble Alpes

La Tronche, , France

Site Status NOT_YET_RECRUITING

Clinique de la Louviere

Lille, , France

Site Status NOT_YET_RECRUITING

Hôpital d'Instruction des Armées Laveran

Marseille, , France

Site Status NOT_YET_RECRUITING

Clinique Beausoleil

Montpellier, , France

Site Status NOT_YET_RECRUITING

CHU Saint Etienne

Saint-Priest-en-Jarez, , France

Site Status NOT_YET_RECRUITING

Asklepios Klinik Hamburg

Hamburg, , Germany

Site Status RECRUITING

Universitatsklinikum Hamburg Eppendorf

Hamburg, , Germany

Site Status RECRUITING

Klinik für HNO-Heilkunde/HNO-Schlaflabor

Lübeck, , Germany

Site Status NOT_YET_RECRUITING

Otto-von-Guericke-Universität Magdeburg

Magdeburg, , Germany

Site Status NOT_YET_RECRUITING

Universitäts-HNO-Klinik Mannheim

Mannheim, , Germany

Site Status NOT_YET_RECRUITING

Klinikum Rechts der Isar Technische Universität München

Munich, , Germany

Site Status RECRUITING

Sint Lucas Andreas Ziekenhus (OLVG)

Amsterdam, , Netherlands

Site Status NOT_YET_RECRUITING

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, , Netherlands

Site Status NOT_YET_RECRUITING

Kantonnspital Baselland-Liestal

Liestal, , Switzerland

Site Status NOT_YET_RECRUITING

Guy's & St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status NOT_YET_RECRUITING

University College London Hospitals NHS Foundation Trust

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Manchester University NHS Trust

Manchester, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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Austria Belgium France Germany Netherlands Switzerland United Kingdom

Central Contacts

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Elyse Ebeling

Role: CONTACT

(763) 250-9432

Facility Contacts

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Dr. Andreas Bischof

Role: primary

Magdalena Sturm

Role: primary

Dorine Van Loo, PhD.

Role: primary

Auregan Milena

Role: primary

Prof. Renaud Tamisier

Role: primary

Dr. Sarah Boulanger

Role: primary

Dr. Stanislas Ballivet de Regloix

Role: primary

Sarah Hammouma

Role: primary

Prof. Frederic Roche

Role: primary

Wenke Pfenning

Role: primary

Prof. Dr. med Arne Boettcher

Role: primary

Dr. med. Armin Steffen

Role: primary

Dr.Stephanie Kühne

Role: primary

Dr. Joachim T Maurer

Role: primary

Lisa Dunker

Role: primary

Anja van de Velde-Muusers

Role: primary

Dr. Marcel Copper

Role: primary

Prof. Dr. Kurt Tschopp

Role: primary

Krizzia Lammas

Role: primary

Omursen Yildirim

Role: primary

Sadie Khwaja

Role: primary

Other Identifiers

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2023-004

Identifier Type: -

Identifier Source: org_study_id

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