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Recruiting NCT06971796

EURO-STIM Registry

— Observational Obstructive Sleep Apnea Obstructive Sleep Apnea (OSA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inspire UAS System.
Who it may be relevant to
Registry conditions: Obstructive Sleep Apnea, Obstructive Sleep Apnea (OSA). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria, Belgium, France, Germany, Netherlands +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device 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.

Primary outcome measures

  • 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.]
  • 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.]
Secondary outcome measures (6)
  • DISE VOTE Classification [Time frame: 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.]
  • Patient Experience with Therapy (PET) [Time frame: 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.]
  • Therapy Use [Time frame: 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.]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 6 centers
  • Angers University Hospital Center — Angers
  • CHU Grenoble Alpes — La Tronche
  • Clinique de la Louviere — Lille
  • Hôpital d'Instruction des Armées Laveran — Marseille
  • Clinique Beausoleil — Montpellier
  • CHU Saint Etienne — Saint-Priest-en-Jarez
Germany · 6 centers
  • Asklepios Klinik Hamburg — Hamburg
  • Universitatsklinikum Hamburg Eppendorf — Hamburg
  • Klinik für HNO-Heilkunde/HNO-Schlaflabor — Lübeck
  • Otto-von-Guericke-Universität Magdeburg — Magdeburg
  • Universitäts-HNO-Klinik Mannheim — Mannheim
  • Klinikum Rechts der Isar Technische Universität München — Munich
United Kingdom · 3 centers
  • Guy's & St Thomas' NHS Foundation Trust — London
  • University College London Hospitals NHS Foundation Trust — London
  • Manchester University NHS Trust — Manchester
Austria · 2 centers
  • Klinikum Klagenfurt, KABEG — Klagenfurt
  • Ordensklinikum Linz — Linz
Netherlands · 2 centers
  • Sint Lucas Andreas Ziekenhus (OLVG) — Amsterdam
  • St. Antonius Ziekenhuis Nieuwegein — Nieuwegein
Belgium · 1 center
  • Universitair Ziekenhuis Antwerpen — Edegem
Switzerland · 1 center
  • Kantonnspital Baselland-Liestal — Liestal

Identifiers

NCT: NCT06971796 · 2023-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗