NCT04031040

A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults

A Post-market Clinical Follow up of the Genio® System for the Treatment of Obstructive Sleep Apnea in Adults.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Nyxoah S.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to confirm the safety and clinical effectiveness of the Genio® system in moderate to severe Obstructive Sleep Apnea (OSA) adult patients over a period of 5 years post-surgery.

Detailed description

This study is a multicenter, prospective single arm PMCF. Following activation of the Genio® system between 6 to 10 weeks post-surgery, patients will be followed at 3 months, 6 months, 9 months, 12 months and then every year for a total period of 5 years after surgery. Phone calls follow-up will be performed at Month 18, Month 30, Month 42 and Month 54.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DEVICE	Genio® system therapy	Hypoglossal nerve stimulation system

Timeline

• Start date: 2019-09-01
• Primary completion: 2026-10-30
• Completion: 2030-10-01
• First posted: 2019-07-24
• Last updated: 2026-03-04

Locations

19 sites across 5 countries: Belgium, France, Germany, Netherlands, Switzerland