Clinical Trials Logo
  1. Home
  2. Sleep Apnea, Obstructive
  3. NCT05592002

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
See also
  Status Clinical Trial Phase
Terminated NCT03605329 - Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS N/A
Completed NCT04912635 - Evaluation of a Health Dashboard Intervention to Improve Engagement With CPAP Therapy in PAP-Naïve Patients: Project Neo N/A
Not yet recruiting NCT05939934 - Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal N/A
Enrolling by invitation NCT02290236 - Monitored Saturation Post-ICU N/A
Terminated NCT02269774 - Origin of Premature Atrial Beats Induced by Simulated Obstructive Sleep Apnea N/A
Completed NCT02088723 - Testing the Elevation as Sleep Apnea Treatment N/A
Completed NCT02261857 - 3D-Printed CPAP Masks for Children With Obstructive Sleep Apnea Early Phase 1
Completed NCT01943708 - Novel Auto-continuous Positive Airway Pressure (CPAP) Validation Phase 3
Completed NCT01181570 - Efficacy and Safety of Adalimumab in Patients With Psoriasis and Obstructive Sleep Apnea Phase 4
Completed NCT00273754 - The Effect of Caffeine on Postextubation Adverse Respiratory Events in Children With Obstructive Sleep Apnea (OSA). Phase 2
Recruiting NCT02166879 - Undetected Sleep Apnea in the Postanesthesia Acute Care Unit (PACU)
Recruiting NCT04963192 - Integrated Management of Chronic Respiratory Diseases N/A
Completed NCT05056766 - How Does the Clinical and Paraclinical Efficacy of an Oral Appliance Evolved According to Propulsion: Control With Each mm of Advancement
Completed NCT04846400 - Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia N/A
Recruiting NCT04314492 - Intracapsular Tonsillectomy in the Treatment of Obstructive Sleep Apnea in Adults N/A
Completed NCT05175287 - OSA (oRisk of Obstructive Sleep Apnea and Traffic Accidents Among Bus Drivers in Ecuador: is There a Significant Association
Active, not recruiting NCT03431038 - Cross-sectional Study of Prevalence Rate of Abdominal Aortic Aneurysm in OSAHS Patients From BTCH N/A
Enrolling by invitation NCT03075787 - Cardiovascular Variability and Heart Rate Response Associated With Obstructive Sleep Apnea N/A
Completed NCT03300037 - HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter Monitor N/A
Recruiting NCT06097949 - AcuPebble to Remotely Monitor Patients With OSA on CPAP Therapy