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

Part of paid clinical trials in Miami, Florida.

Sponsor
Nyxoah Inc.
Study ID
NCT07331285
Status
Recruiting
Apply to this trial

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

First listed
Jan 9, 2026
Start date
Jun 30, 2026
Status verified
Jun 2026
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 (2)

FacilityCityStateZIPSite coordinators
PharmaDev Clinical Research Institute, LLCMiamiFlorida33176
Olivia Falcon Valdes
[email protected]
305-420-5636
Nyxoah, IncSummitNew Jersey07901
Lorin Petre
[email protected]
+1 (908) 263-0228
Alicia Castonguay
[email protected]

Find similar trials in Miami, FL

By research site
PharmaDev Clinical Research Institute, LLC· Miami, FLNyxoah, Inc· Summit, NJ

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