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

Part of paid clinical trials in Summit, New Jersey.

Sponsor
Nyxoah Inc.
Study ID
NCT07331285
Status
Not Yet Recruiting

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Conditions

  • Obstructive Sleep Apnea

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Dec 2025
Primary completion
Oct 31, 2028
Completion
Oct 31, 2032

Study Design

Enrollment
229 participants (estimated)

Arms

  • Arm: Genio System 2.1
    This is a single-arm study. All consented and eligible subjects will be implanted with the Genio 2.1 System.

Primary Outcome Measure

Change in Apnea Hypopnea Index (AHI4%) [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Nyxoah, IncSummitNew Jersey07901
Lorin Petre
[email protected]
908-263-0228
Alicia Castonguay
[email protected]

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By research site
Nyxoah, Inc· Summit, NJ

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