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Clinical Trials in Germany / NCT04031040
Active, not recruiting Not applicable

A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults

NCT04031040 · tracked via the Priya Life Science Germany tracker
Sponsor
Phase
Not applicable
Started
2019-09-01
Last updated
2026-03-04

Condition(s) studied

Obstructive Sleep Apnea

Investigational drug(s) / intervention(s)

Genio® system therapy

Genio® system therapy: Hypoglossal nerve stimulation system

Study summary

The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio® system in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 5 years post-surgery.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Body Mass Index (BMI) \< 35 kg/m2 * AHI between 15 to 65 events/hour documented by the closest PSG performed at the time of the patient ICF signature and within maximum 12 months of screening and fulfilling the required technical criteria or during the screening phase. * Has either not tolerated, has failed or refused Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) treatments. Exclusion Criteria: * Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment; * Taking medication that in the opinion of the Investigator may alter consciousness, the pattern of respiration, or sleep architecture; * Major anatomical or functional abnormalities that would impair the ability of the Genio® system to treat OSA; * Inadequately treated psychiatric disease that prevent patient compliance with the requirements of the investigational study testing; * Life expectancy \< 12 months; * Participation in another clinical study (excluding registries) during the study period (3 years).

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn Antwerp Belgium
Universitair Ziekenhuis Antwerpen Antwerp Belgium
CHU - Angers Angers France
Hôpital Henri-Mondor AP-HP Créteil France
Hôpital Privé La Louvière Lille France
Clinique Beau-Soleil Montpellier France
Hôpital Bichat, Assistance Publique - Hôpitaux de Paris Paris France
CEREVES Paris Jean Jaurès - Centre du sommeil Paris France
Hôpital Tenon AP-HP Paris France
Clinique Mutualiste de la Sagesse Rennes France
Polyclinique Saint Laurent Rennes France
CHU Toulouse Toulouse France
Asklepios Klinikum Harburg, Abt. für HNO-Heilkunde, Kopf- und Halschirurgie Hamburg Germany
HNO-Klinik des Universitätsklinikums Jena Jena Germany
Klinik für HNO-Heilkunde, Kopf- und Halschirurgie, Schlafmedizinisches Zentrum Mannheim Germany
Klinikum rechts der Isar der TU München München Germany
Helios Universitätsklinikum Wuppertal,Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie Wuppertal Germany
Onze Lieve Vrouwe Gasthuis Amsterdam Netherlands
Kantonsspital Baselland, Klinik für HNO-Krankheiten, Kopf- und Gesichtschirurgie Liestal Switzerland

More Nyxoah S.A. trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04031040 on ClinicalTrials.gov ↗ ← All trials in Germany