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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: Genio® system therapy

Detailed Description

This study is a multicenter, prospective single arm PMCF. Following activation of the Genio® system between 6 to 10 weeks post-surgery, patients will be followed at 3 months, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery. Phone calls follow-up will be performed at Month 18, Month 30, Month 42 and Month 54.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Antwerp, Belgium, 2650
    • Universitair Ziekenhuis Antwerpen
  • Antwerp, Belgium, 2170
    • Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn
• France
  • Angers, France, 49933
    • CHU - Angers
  • Créteil, France, 94010
    • Hôpital Henri-Mondor AP-HP
  • Lille, France, 59800
    • Hôpital privé La Louvière
  • Montpellier, France, 34070
    • Clinique Beau-Soleil
  • Paris, France, 75020
    • Hôpital Tenon AP-HP
  • Paris, France, 75018
    • Hôpital Bichat, Assistance Publique - Hôpitaux de Paris
  • Paris, France, 75019
    • CEREVES Paris Jean Jaurès - Centre du sommeil
  • Rennes, France, 35000
    • Clinique Mutualiste de la Sagesse
  • Rennes, France, 35700
    • Polyclinique Saint Laurent
  • Toulouse, France, 31400
    • Chu Toulouse
• Germany
  • Hamburg, Germany, 21075
    • Asklepios Klinikum Harburg, Abt. für HNO-Heilkunde, Kopf- und Halschirurgie
  • Jena, Germany, 07747
    • HNO-Klinik des Universitätsklinikums Jena
  • Mannheim, Germany, 68167
    • Klinik für HNO-Heilkunde, Kopf- und Halschirurgie, Schlafmedizinisches Zentrum
  • München, Germany, 81675
    • Klinikum rechts der Isar der TU München
  • Wuppertal, Germany, 42283
    • Helios Universitätsklinikum Wuppertal,Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie
• Netherlands
  • Amsterdam, Netherlands, 1061 AE
    • Onze Lieve Vrouwe Gasthuis
• Switzerland
  • Liestal, Switzerland, 4410
    • Kantonsspital Baselland, Klinik für HNO-Krankheiten, Kopf- und Gesichtschirurgie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Genio® system therapy; Following activation of the Genio® system at 8 weeks post-surgery, patients will be followed at 12 weeks, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery.	Device: Genio® system therapy; Hypoglossal nerve stimulation system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Apnea-Hypopnea Index from baseline	Change in Apnea-Hypopnea Index (AHI) from baseline as measured by sleep lab	12 months post-surgery
Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire	Change in the quality of life measured by the Functional Outcomes of Sleep Questionnaire (FOSQ)	12 months post-surgery
Incidence of device-related Serious Adverse Events (SADEs)	Incidence of device-related Serious Adverse Events (SADEs)	12 months post-surgery

Collaborators and Investigators

• Sponsor: Nyxoah S.A.
• Investigators: Principal Investigator: Joachim T. Maurer, MD, Klinik für HNO-Heilkunde, Mannheim

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: July 18, 2019
• First Submitted That Met QC Criteria: July 21, 2019
• First Posted (Actual): July 24, 2019

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Wake Disorders; Apnea; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: CL-GEN-002068

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No