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Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation

NCT07331285 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 229

Last updated 2026-03-05

No results posted yet for this study

Summary

The objective of the BREATHE study is to demonstrate the continued safety and effectiveness of the Genio® System in treating subjects diagnosed with moderate to severe obstructive sleep apnea (OSA) who are intolerant to or failed/refused PAP treatments.

Conditions

Interventions

DEVICE

This is a single arm study, all consented and eligible subjects will be implanted with the Genio® System 2.1

Genio® System 2.1

Sponsors & Collaborators

  • Nyxoah Inc.

    lead INDUSTRY

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2028-10-31
Completion
2032-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07331285 on ClinicalTrials.gov