U.S., Jan. 10 -- ClinicalTrials.gov registry received information related to the study (NCT07331285) titled 'Bi-lateral HGN Therapy in Real-World Patients -Post Approval Research Investigation' on Dec. 29, 2025.
Brief Summary: The objective of the BREATHE study is to demonstrate the continued safety and effectiveness of the Genio(R) System in treating subjects diagnosed with moderate to severe obstructive sleep apnea (OSA) who are intolerant to or failed/refused PAP treatments.
Study Start Date: April, 2026
Study Type: OBSERVATIONAL
Condition:
Obstructive Sleep Apnea
Intervention:
DEVICE: This is a single arm study, all consented and eligible subjects will be implanted with the Genio(R) System 2.1
Genio(R) System 2.1
Recruitment St...