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

Nyxoah S.A.42 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

Genio(TM) bilateral hypoglossal nerve stimulation systemDEVICE

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (4)

Westmead Private Hospital

Westmead, New South Wales, Australia

Wollongong Private Hospital

Wollongong, New South Wales, Australia

Institute Breathing and Sleep Austin Hospital

Heidelberg, Victoria, Australia

Hollywood Hospital

Nedlands, Western Australia, Australia

Outcomes

Primary Outcomes

Incidence of serious device-related adverse events recorded during the study

Time frame: 6 months

Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)

Time frame: Change from baseline to 6 months post implantation in the apnoea-hypopnea index (AHI)

Secondary Outcomes

Change from baseline to 6, 12, 24 and 36 months post implantation in Oxygen Desaturation Index (ODI)

Time frame: 6,12, 24, 36 months

Change from baseline to 12, 24 and 36 months post implantation in Apnea Hypopnea Index (AHI)

Time frame: 12, 24, 36 months

Data from ClinicalTrials.gov

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