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

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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obstructive Sleep Apnea of Adult
• Intervention / Treatment: Device: Genio System

Detailed Description

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.

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.

• Study Type: Observational
• Enrollment (Estimated): 39

Contacts and Locations

• Study Contact: Name: Dan Mans; Phone Number: +17633703594; Email: Dan.Mans@Nyxoah.com
• Study Contact Backup: Name: Sharondeep Gill; Email: Sharondeep.Gill@nyxoah.com

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2145
      • Westmead Public Hospital
      • Contact: John Wheatley, MBBS
      • Principal Investigator: John Wheatley, MBBS
    • Sydney, New South Wales, Australia, 2037
      • The Woolcock Institute Of Medical Research
      • Contact: Ronald Grunstein
      • Principal Investigator: Ronald Grunstein, MBBS
    • Sydney, New South Wales, Australia, 2500
      • Illawarra ENT and Head & Neck Clinic
      • Contact: Stuart MacKay, MBBS
      • Principal Investigator: Stuart MacKay, MBBS
  • Queensland
    • Brisbane, Queensland, Australia, 4000
      • Complete ENT
      • Contact: Leon Kitipornchai, MBBS
      • Principal Investigator: Leon Kitipornchai, MBBS
  • Victoria
    • Melbourne, Victoria, Australia, 3084
      • Institute for Breathing and Sleep (IBAS)
      • Contact: Maree Barnes, MBBS
      • Principal Investigator: Maree Barnes, MBBS
    • Melbourne, Victoria, Australia, 3168
      • Monash Health - Department of Respiratory and Sleep Medicine
      • Contact: Darren Mansfield
      • Principal Investigator: Darren Mansfield, MBBS
  • Western Australia
    • Perth, Western Australia, Australia, 6009
      • Perth Head & Neck Surgery
      • Contact: Richard Lewis, MBBS
      • Principal Investigator: Richard Lewis, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

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 in Australia.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

OLE Subjects; 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 and having the device in-situ at the time of enrollment (with therapy activated or de-activated).

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term safety	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).	Yearly (until commercial availability of the device in Australia OR until no subjects remain implanted), anticipated average 5 years"

Collaborators and Investigators

• Sponsor: Nyxoah S.A.
• Collaborators: Nyxoah Pty. Ltd.
• Investigators: Principal Investigator: Richard Lewis, MBBS, Perth Head & Neck Surgery

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2025
• Primary Completion (Estimated): July 17, 2029
• Study Completion (Estimated): July 17, 2029

Study Registration Dates

• First Submitted: June 16, 2023
• First Submitted That Met QC Criteria: July 10, 2023
• First Posted (Actual): July 11, 2023

Study Record Updates

• Last Update Posted (Actual): June 4, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: OSA HGNS Hypoglossal Nerve Stimulation
• 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-OLE2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No