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

Key facts

Who runs it
Nyxoah S.A.
Where
Brisbane, Melbourne, Perth, and Sydney, AustraliaSee the 7 sites
Trial code
Status
Not yet recruiting
People taking part
39 people, planned
Started
Nov 2025
Expected to end
17 Jul 2029
Type of study
Observational
Treatments tested
  • Genio System
Record updated
4 June 2025

Who can take part

Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

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Who can take part

  • 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)

Who cannot take part

  • None

Where in Australia

  • Complete ENTBrisbane, AustraliaContact: Leon Kitipornchai, MBBSNo longer taking part
  • Institute for Breathing and Sleep (IBAS)Melbourne, AustraliaContact: Maree Barnes, MBBSNo longer taking part
  • Monash Health - Department of Respiratory and Sleep MedicineMelbourne, AustraliaContact: Darren MansfieldNo longer taking part
  • Perth Head & Neck SurgeryPerth, AustraliaContact: Richard Lewis, MBBSNo longer taking part
  • Illawarra ENT and Head & Neck ClinicSydney, AustraliaContact: Stuart MacKay, MBBSNo longer taking part
  • The Woolcock Institute Of Medical ResearchSydney, AustraliaContact: Ronald GrunsteinNo longer taking part
  • Westmead Public HospitalSydney, AustraliaContact: John Wheatley, MBBSNo longer taking part

About the trial

What the trial wants to find out

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.

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(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.

The group in the trial

  • 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).

    Treatment: Genio System

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official 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.
Record updated
4 June 2025