Clinical trial NCT05939141: An Extension Study to Assess the Long-term Safety of the Genio® System
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.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obstructive Sleep Apnea of Adult
Keywords: OSA HGNS Hypoglossal Nerve Stimulation
Lead sponsor: Nyxoah S.A.
Sponsor class: INDUSTRY
Collaborators: name: Nyxoah Pty. Ltd.
First posted: 2023-07-11
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Long-term safety
timeFrame: Yearly (until commercial availability of the device in Australia OR until no subjects remain implanted), anticipated average 5 years"
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: The Woolcock Institute Of Medical Research
state: New South Wales
city: Sydney
country: Australia
facility: Westmead Public Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Illawarra ENT and Head & Neck Clinic
state: New South Wales
city: Brisbane
country: Australia
facility: Complete ENT
state: Queensland
city: Melbourne
country: Australia
facility: Institute for Breathing and Sleep (IBAS)
state: Victoria
city: Melbourne
country: Australia
facility: Monash Health - Department of Respiratory and Sleep Medicine
state: Victoria
city: Perth
country: Australia
facility: Perth Head & Neck Surgery
state: Western Australia
Study officials:
affiliation: Perth Head & Neck Surgery
name: Richard Lewis, MBBS
role: PRINCIPAL_INVESTIGATOR
References: