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Safety and Effectiveness of the Genio® bilAteral Stimulation for Treatment of Complete Concentric CollapsE and OSA. — ACCCESS  

Sleep Apnea, Obstructive Clinical Trial

Official title:
A Multicenter Study to Assess the Safety and Effectiveness of the Genio® Dual-sided Hypoglossal Nerve Stimulation System for the Treatment of Obstructive Sleep Apnea in Subjects With Complete Concentric Collapse of the Soft Palate.

Clinical Trial Summary

The solution offered by the Genio System to treat OSA patients with CCC using bilateral HGNS has a favorable risk-benefit ratio, as demonstrated by evidence from 2 studies.

Clinical Trial Description

Nyxoah has developed the Genio® 2.1 System with the intention of treating patients with moderate to severe obstructive sleep apnea. In overview, the System includes an Implantable Stimulator (IS) designed to stimulate the hypoglossal nerve branches (i.e., both the left and the right). The IS does not include a battery but receives energy pulses transmitted by an Activation Chip (AC) which is attached to an adhesive Disposable Patch (DP) and placed on the patient's skin under the chin. Stimulation of the hypoglossal nerve causes the tongue muscles to contract with the intention to maintain an open airway. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05592002
Study type Interventional
Source Nyxoah S.A.
Contact Joyce Babayan
Phone 818-388-1001
Email Joyce.Babayan@nyxoah.com
Status Recruiting
Phase N/A
Start date December 28, 2022
Completion date October 2027
View Details
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