BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse

NATerminatedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

January 10, 2019

Primary Completion Date

June 28, 2021

Study Completion Date

June 18, 2024

Conditions
Obstructive Sleep Apnea
Interventions
DEVICE

Genio(TM) bilateral hypoglossal nerve stimulation system

Subjects will be consented, enrolled and eligibility criteria checked. If the subject is eligible, subject will proceed with the Genio(TM) implant implantation. Six (6) weeks after implantation, the implant will be activated and the subject will be assessed at 1 month plus 1 week, 2, 3, 4, 5 and 6 month(s) after implantation

Trial Locations (4)

2145

Westmead Private Hospital, Westmead

2500

Wollongong Private Hospital, Wollongong

3084

Institute Breathing and Sleep Austin Hospital, Heidelberg

6005

Hollywood Hospital, Nedlands

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Nyxoah S.A.

INDUSTRY

NCT03763682 - BilatEral Hypoglossal Nerve StimulaTion for TreatmEnt of ObstRuctive SLEEP Apnoea With and Without Complete Concentric Collapse | Biotech Hunter | Biotech Hunter