MedTrace Logo

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

NCT05939141 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 39

Last updated 2025-06-04

No results posted yet for this 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.

Conditions

  • Obstructive Sleep Apnea of Adult

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Nyxoah Pty. Ltd.

    collaborator INDUSTRY

  • Nyxoah S.A.

    lead INDUSTRY

Principal Investigators

  • Richard Lewis, MBBS · Perth Head & Neck Surgery

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-30
Primary Completion
2029-07-17
Completion
2029-07-17

Countries

  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05939141 on ClinicalTrials.gov