An Extension Study to Assess the Long-term Safety of the Genio® System

NCT05939141 · tracked via the Priya Life Science Australia tracker

Sponsor

Nyxoah S.A

Phase

Observational

Started

2025-11

Last updated

2025-06-04

Condition(s) studied

Obstructive Sleep Apnea of Adult

Investigational drug(s) / intervention(s)

Genio System

Genio System: All participants have previously been implanted with a Genio® system implantable stimulator. This research is observational in nature (long term safety follow-up) and participants will not be exposed to additional procedures. The Genio System comprises of a bilateral Implantable Stimulator (IS), which is implanted via a minimally invasive surgery procedure and positioned over the genioglossus muscle with its electrodes positioned over both the left and right hypoglossal nerve branches. Stimulation of the hypoglossal nerve causes the tongue muscles to contract with the intention to maintain an open airway. The Implantable Stimulator receives energy pulses transmitted via the DP placed under the patient's chin and connected to the Activation Chip (AC), which contains the patient's stimulation parameters and contain a battery that provides energy.

Study summary

The objective of this study is to assess the long-term safety of the Genio® system in adult OSA patients with and without complete concentric collapse of the soft palate who have successfully been implanted with the Genio IS in a Nyxoah sponsored Clinical Investigation.

(Serious) Adverse Device Effects and Device Deficiencies in subjects previously implanted with a Nyxoah Genio implantable stimulator (IS) and having the IS still in-situ (with therapy activated or deactivated) will be collected.

The main question it aims to answer is: what is the long term safety profile of the Genio System?

Participants will be asked to refer back to the site per standard of care and report on any (Serious) Adverse Device Effects and Device Deficiencies that may have occurred.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Accepted

Inclusion Criteria: * Subject voluntarily signed an Informed Consent Form * Subject is currently implanted with a Genio® Implantable Stimulator (IS), with therapy active or inactive, and was included in and subsequently exited a Nyxoah sponsored clinical investigation (either by study completion or withdrawal). These studies include, but are not limited to BLAST OSA (CL-GEN-001203), BETTER SLEEP (CL-GEN-001908), DREAM (CL-GEN-002033) or, subject is currently implanted with a Genio® Implantable Stimulator (IS) and accessing therapy via the TGA special access scheme (SAS). Exclusion Criteria: * None

Primary outcome measure(s)

Long-term safety — Yearly (until commercial availability of the device in Australia OR until no subjects remain implanted), anticipated average 5 years"
Long term safety of the Genio System as measured by the rate and type of Adverse Device Effects, Serious Adverse device Effects and Device Deficiencies overtime in subjects in Australia previously implanted with a Nyxoah Genio implantable stimulator (IS) and having the IS still in-situ (with therapy activated or deactivated).

Trial sites (7)

Facility	City	Region
The Woolcock Institute Of Medical Research	Sydney	New South Wales
Westmead Public Hospital	Sydney	New South Wales
Illawarra ENT and Head & Neck Clinic	Sydney	New South Wales
Complete ENT	Brisbane	Queensland
Institute for Breathing and Sleep (IBAS)	Melbourne	Victoria
Monash Health - Department of Respiratory and Sleep Medicine	Melbourne	Victoria
Perth Head & Neck Surgery	Perth	Western Australia

More Nyxoah S.A. trials in Australia

Dual-sided Hypoglossal neRvE stimulAtion for the treatMent of Obstructive Sleep Apnea (DREAM) Active, not recruiting

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 NCT05939141 on ClinicalTrials.gov ↗ ← All trials in Australia