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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Multicentre, Prospective, Open-label, 2 Groups Study to Assess the Safety and Performance of the Genio™ Bilateral Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnoea in Adult Patients With and Without Complete Concentric Collapse of the Soft Palate

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Genio(TM) bilateral hypoglossal nerve stimulation system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: prospective, open-label, 2 groups
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genio(TM) system therapy<br>Genio(TM) bilateral hypoglossal nerve stimulation system | Device: Genio(TM) bilateral hypoglossal nerve stimulation system<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious device-related adverse events recorded during the study |  | 6 months | 
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to 6, 12, 24 and 36 months post implantation in Oxygen Desaturation Index (ODI) |  | 6,12, 24, 36 months | 
| Change from baseline to 12, 24 and 36 months post implantation in Apnea Hypopnea Index (AHI) |  | 12, 24, 36 months |