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Frequently asked
questions

This section presents general information about medical conditions and potential treatments. It is not medical advice. If you have any medical questions, please consult your doctor.

Obstructive Sleep Apnea

How is OSA diagnosed?


To diagnose your condition, your doctor may need to do an evaluation based on your signs and symptoms and carry out an examination and tests. Your doctor may refer you to a sleep specialist in a sleep clinic for a thorough evaluation.

A physical examination will take place and your doctor will examine the back of your throat, mouth and nose for extra tissue or abnormalities. Additional checks may also be necessary. Your doctor may also refer you to an ear, nose and throat doctor to rule out any anatomic blockage in your nose or throat. A sleep specialist may conduct additional evaluations to diagnose your condition, determine the severity and plan your treatment. The evaluation may involve overnight monitoring of your breathing and other bodily functions as you sleep.

Tests

Two type of tests can detect obstructive sleep apnea:

  • Polysomnography: this is a sleep study which hooks you up to equipment to monitor your heart, lung and brain activity, breathing patterns, limb movements and blood oxygen levels while sleeping.
  • Home sleep apnea test: under certain circumstances, your doctor may give you a home version of the sleep test (polygraphy) to diagnose obstructive sleep apnea.

   

Is there any clinical study or data on the Genio® OSA treatment?


The BLAST OSA(1) study was completed in 2019, resulting in the CE mark for the Genio® system. The BLAST OSA study demonstrated positive outcomes in terms of safety and performance of the Genio® system. The patient satisfaction was very high, with 82% of the patients claiming that they were extremely or somewhat satisfied by the Genio® system.91% of the patients reported using the Genio® system for more than 5 days a week and 77% reported a nightly use of more than 5 hours a night. The percentage of bed partners reporting loud, very intense snoring, or leaving the bedroom due to participant snoring decreased from 96% to 35%. 91% of the patients reported using the Genio® system for more than 5 days a week.

1. Eastwood PR, Barnes M, MacKay SG, et al. Bilateral Hypoglossal Nerve Stimulation for Treatment of Adult Obstructive Sleep Apnea. Eur Respir J 2019

   

Genio® Implant and Use

After placing the implant, how long does it take until I can start using the activation chip?


A few things need to happen between surgery and the activation of the Genio® system. First, your body needs to heal and recover from the surgical intervention. After six to eight weeks, the healing period has finished and you will receive personal assistance to show you how your Genio® system works and first activate the system.

In the personal training sessions, you will experience the feeling of the stimulation of your tongue muscle nerves for the first time. The feeling and sensation of this specific tongue movement might take a while to become accustomed to. Also, sensitivity and intensity of this new experience can vary between people.

During these personal sessions, you will need at least two sleep studies to benchmark and adjust the settings of your Genio® system. After this, you can be given the green light to start using your Genio® Activation Chip. Your doctor may need to schedule additional sleep studies to monitor and optimize your Genio® therapy settings.

   

Why do I need to keep shaving my chin from the moment I start using Genio®?


The proper operation of the Activation Chip and the implant relies heavily on the patch. This patch needs to stick properly under your chin. The adhesive part will stay better in its place when the chin is free of any facial hair. 

   

Can the Activation Chip detach from the adhesive patch during my sleep?


The Disposable Patch and the Activation Chip are meant to function as one part. The chip clicks firmly onto the patch to prevent any disconnection during the night.

   

Indications and Market Availability

Which patients are indicated for Genio®?


The Genio® system is used as a second line therapy to treat adult patients suffering from moderate to severe Obstructive Sleep Apnea (OSA). The Genio® system is used in adult patients who have not tolerated, have failed or refused Positive Airway Pressure (PAP) treatments. Additional requirements:

  • Apnea Hypopnea Index (AHI) greater or equal to 15 and less than or equal to 65
  • Body Mass Index (BMI) less than 35 kg/m2
  • Absence of Complete Concentric Collapse (CCC) of the upper airway

   

Where is Genio® available? 


Genio® received the CE mark in March 2019 and is approved for use in Europe. Currently, Genio® is not commercially available in the United States.

   

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All rights reserved © 2020 Nyxoah S.A. All content on this presentation, including the texts, trademarks, service marks, logos, illustrations, photos, graphics, design etc., are the property of Nyxoah SA. Nyxoah S.A. owns all rights with respect to any of their trademarks, service marks, logos, and copyrighted works appearing on this presentation. Patented and design protected technology. Device not for sale in U.S. The Genio® system by Nyxoah is intended to be used for patients who suffer from moderate to severe Obstructive Sleep Apnea (AHI of 15 to 65), have not tolerated, failed or refused PAP therapy and are not significantly overweight. Reviewed and approved: February 2020
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