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

Obstructive Sleep Apnea of Adult Clinical Trial

— OLE  

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05939141
• Other study ID #: CL-OLE2023
• Status: Not yet recruiting
• Start date: July 17, 2023
• Est. completion date: July 17, 2028

Study information

• Verified date: June 2023
• Source: Nyxoah S.A.
• Contact: Dan Mans
• Phone: +17633703594
• Email: Dan.Mans[@]Nyxoah.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 39
• Est. completion date: July 17, 2028
• Est. primary completion date: July 17, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea of Adult
• Sleep Apnea, Obstructive

Intervention

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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Nyxoah S.A.	Nyxoah Pty. Ltd.

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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"