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

Not Applicable

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: Genio(TM) bilateral hypoglossal nerve stimulation system

• Registration Number: NCT03763682
• Lead Sponsor: Nyxoah S.A.

Brief Summary

The objective of this study is to explore the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate over a period of 4.5 months of treatment (i.e. 6 months post-surgery) measured by the AHI, at rest to determine if there is a difference in performance between the two populations.

Detailed Description

This is a prospective, open-label, multicentric, 2 groups study to assess the safety and performance of the Genio™ system in adult obstructive sleep apnoea (OSA) patients with and without complete concentric collapse of the soft palate. Participants will be consented, enrolled and eligibility criteria checked. If the participant is eligible, participant will proceed with the Genio™ IS implantation. Six (6) weeks after implantation, the implant will be activated and study visits will be scheduled at Week 7, Month 2, Month 3, Month 4, Month 5 and Month 6.

Study Timeline

• Study First Submitted: 2018-12-03
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-04
• Study Start: 2019-01-10
• Primary Completion: 2021-06-28
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-11
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Man or woman between 21 and 75 years of age
• Body mass index (BMI) ≤ 32 kg/m2
• Obstructive apnoea-hypopnea index (AHI) of 15-50 events/hour
• Participants who have either not tolerated, have failed or refused positive airway pressure (PAP) treatments.

Exclusion Criteria

• Unable or incapable of providing informed written consent
• Unwilling or incapable of returning to all follow-up visits and sleep studies, including evaluation procedures and filling out questionnaires

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Genio(TM) system therapy	Genio(TM) bilateral hypoglossal nerve stimulation system	Genio(TM) bilateral hypoglossal nerve stimulation system

Primary Outcome Measures

Name	Time	Method
Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)	Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)
Incidence of serious device-related adverse events recorded during the study	6 months

Secondary Outcome Measures

Name	Time	Method
Change from baseline to 12, 24 and 36 months post implantation in Apnea Hypopnea Index (AHI)	12, 24, 36 months
Change from baseline to 6, 12, 24 and 36 months post implantation in Oxygen Desaturation Index (ODI)	6,12, 24, 36 months

Trial Locations

Locations (4)

Institute Breathing and Sleep Austin Hospital; 🇦🇺 Heidelberg, Victoria, Australia

Hollywood Hospital; 🇦🇺 Nedlands, Western Australia, Australia

Westmead Private Hospital; 🇦🇺 Westmead, New South Wales, Australia

Wollongong Private Hospital; 🇦🇺 Wollongong, New South Wales, Australia