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NCT Number: NCT05939141

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

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.

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Key information

Conditions

Obstructive Sleep Apnea of Adult

Sex eligibility

All sexes

Study type

Observational

Primary location

Illawarra ENT and Head & Neck Clinic, Sydney, New South Wales, Australia

About this study

All subjects that have previously participated in a Nyxoah sponsored clinical investigation in Australia, and who are currently still implanted with an implantable stimulator (with therapy activated or de-activated) will be asked to participate in this long-term safety follow-up study and will be asked to report any (Serious) Adverse Device Effects and Device Deficiencies that may have occurred.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Genio System

Device

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.

Primary outcomes

Long-term safety

Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Dan Mans

CONTACT

[email protected]

+17633703594

Sharondeep Gill

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Nyxoah S.A.

Industry

Collaborators

Nyxoah Pty. Ltd.

Registry information

Official study title

A Prospective, Open-label, Multicentric Extension Study to Assess the Long-term Safety of the Genio® System in Study Subjects Who Have Been Implanted With the Genio® Implantable Stimulator (IS) for the Treatment of OSA in Adult Patients.

Acronym: OLE

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2029
First posted: Jul 11, 2023
Registry last updated: Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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