Study Results
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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RECRUITING
1000 participants
OBSERVATIONAL
2025-05-26
2035-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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.
Eligibility Criteria
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Inclusion Criteria
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
1. Has a life expectancy of less than one year
2. Any reason the clinician deems patient is unfit for participation in the study
18 Years
ALL
No
Sponsors
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Inspire Medical Systems, Inc.
INDUSTRY
Responsible Party
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Locations
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Klinikum Klagenfurt, KABEG
Klagenfurt, , Austria
Ordensklinikum Linz
Linz, , Austria
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Angers University Hospital Center
Angers, , France
CHU Grenoble Alpes
La Tronche, , France
Clinique de la Louviere
Lille, , France
Hôpital d'Instruction des Armées Laveran
Marseille, , France
Clinique Beausoleil
Montpellier, , France
CHU Saint Etienne
Saint-Priest-en-Jarez, , France
Asklepios Klinik Hamburg
Hamburg, , Germany
Universitatsklinikum Hamburg Eppendorf
Hamburg, , Germany
Klinik für HNO-Heilkunde/HNO-Schlaflabor
Lübeck, , Germany
Otto-von-Guericke-Universität Magdeburg
Magdeburg, , Germany
Universitäts-HNO-Klinik Mannheim
Mannheim, , Germany
Klinikum Rechts der Isar Technische Universität München
Munich, , Germany
Sint Lucas Andreas Ziekenhus (OLVG)
Amsterdam, , Netherlands
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, , Netherlands
Kantonnspital Baselland-Liestal
Liestal, , Switzerland
Guy's & St Thomas' NHS Foundation Trust
London, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
Manchester University NHS Trust
Manchester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Dr. Stanislas Ballivet de Regloix
Role: primary
Other Identifiers
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2023-004
Identifier Type: -
Identifier Source: org_study_id
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