Reviewing the Genio System for Sleep Apnea

Presented by Victor, ENT Surgeon, Royal National ENT Hospital

Introduction

• Victor is an ENT surgeon specializing in snoring and sleep apnea.
• The focus of the presentation is the Genio system by NIXA, a device for moderate or severe obstructive sleep apnea.
• Victor's objective: Explain how it works, review medical evidence, and give personal impressions.
• Disclosure: Victor is not paid by NIXA but is working to make the device available for free on the NHS in Britain.

Device Overview

• Genio System by NIXA: Targets people with moderate to severe sleep apnea, especially those who can't use CPAP or mandibular advancement devices.
• How it Works: Stimulates the hypoglossal nerve to move the tongue forward, opening the airway.
• Anatomy: Hypoglossal nerve runs underneath the chin to the tongue.
• Installation:
  • Implanted under the skin near the hypoglossal nerves.
  • Minor surgery of 30-60 minutes, outpatient procedure.
  • Device is small, covered in soft plastic.
  • Does not include an implanted battery, unlike other devices.
  • Battery: External, worn under the chin nightly, charged wirelessly.
  • Users must wear a sticker to hold the battery in place, cannot have a large beard.
  • Advantages: No need for another operation every 10 years to replace a battery.
  • Distance limitation: Battery must be within 3.5 cm of the implant; possible removal of neck fat during surgery if needed.

Medical Evidence

1. Case Study in Laryngoscope Journal:

   • Subject: 60-year-old woman with moderate sleep apnea.
   • Results: AHI dropped from 24.6 to 1.3.
   • Context for AHI: Less than 5 is normal, 5-15 is mild, 15-30 is moderate, over 30 is severe.

2. 22-Patient Study, 8 Hospitals in France and Australia:

   • 50% reduction in AHI on average.
   • Comparable to CPAP results but removes need for masks.
   • Side effects:
     • Pain or difficulty swallowing: 30%.
     • Speaking issues: 26%.
     • Blood clots: 19%.
     • Bruising: 19%.
     • Tongue issues: 11%.
     • Some had nerve damage, most transient.
     • Issues with stickers: 30% initially, 1% ongoing.

Personal Impressions

• Advantages:
  • Bilateral hypoglossal nerve stimulation.
  • No internal battery needing replacement.
  • Potentially transformative for sleep apnea treatment.
• Disadvantages:
  • Need to wear and charge external battery nightly.
  • Initial side effect concerns, though mostly temporary.

Conclusion

• Future studies needed to solidify efficacy.
• Victor is advocating for the device to be made available for free in the NHS.
• Reminder to like and subscribe to help disseminate information about sleep apnea.

Closing

• Thank you for watching and supporting the channel!