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

Obstructive Sleep Apnea Clinical Trial

— EliSA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04031040
• Other study ID #: CL-GEN-002068
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: October 30, 2025

Study information

• Verified date: January 2022
• Source: Nyxoah S.A.
• Contact: Jey Subbaroyan, PhD
• Phone: +1 (734) 277-3273
• Email: Jey.Subbaroyan[@]Nyxoah.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio™ system, used according to its instructions for use, in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 3 years post-surgery.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: October 30, 2025
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI) < 35 kg/m2
• AHI between 15 to 65 events/hour documented by a PSG during the screening phase.
• Has either not tolerated, has failed or refused Positive Airway Pressure (PAP) or Mandibular Advancement Device (MAD) treatments.

Exclusion Criteria:

• Night shift worker
• Significant comorbidities that contraindicates surgery
• Life expectancy < 12 months
• Participation in another clinical study (excluding registries) during the study period (3 years).

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Genio(TM) system therapy
Hypoglossal nerve stimulation system

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Antwerpen	Antwerp
Belgium	Ziekenhuis Netwerk Antwerpen - ZNA Jan Palfijn	Antwerp
France	CHU - Angers	Angers
France	Centre Hospitalier Intercommunal de Créteil	Créteil
France	Hôpital Henri-Mondor AP-HP	Créteil
France	Hôpital Privé La Louvière	Lille
France	Clinique Beau-Soleil	Montpellier
France	CEREVES Paris Jean Jaurès - Centre du sommeil	Paris
France	Hôpital Bichat, Assistance Publique - Hôpitaux de Paris	Paris
France	Hôpital Tenon AP-HP	Paris
France	CHU - Poitiers	Poitiers
France	Clinique Mutualiste de la Sagesse	Rennes
France	Polyclinique Saint Laurent	Rennes
France	CHU Toulouse	Toulouse
Germany	Klinik für Hals-, Nasen-, Ohrenheilkunde der Charité am Standort CCM Charité - Universitätsmedizin Berlin	Berlin
Germany	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	Klinik und Poliklinik für Hals-Nasen-Ohrenheilkunde Universitätsklinikum Regensburg	Regensburg
Germany	Helios Universitätsklinikum Wuppertal,Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie	Wuppertal
Netherlands	Onze Lieve Vrouwe Gasthuis	Amsterdam
Switzerland	Kantonsspital Baselland, Klinik für HNO-Krankheiten, Kopf- und Gesichtschirurgie	Liestal

Sponsors (1)

Lead Sponsor	Collaborator
Nyxoah S.A.

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Netherlands,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of all reported Serious Adverse Events (SAEs) and all procedure- or device-related Adverse Events (AEs)	Incidence of all reported Serious Adverse Events (SAEs) and all procedure- or device-related Adverse Events (AEs) reported during the study	12 months post-surgery
Primary	Change in Apnea-Hypopnea Index from baseline	Change in Apnea-Hypopnea Index (AHI) from baseline as measured by sleep lab	12 months post-surgery
Primary	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