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Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation — OSPREY  

Obstructive Sleep Apnea Clinical Trial

Official title:
Treating Obstructive Sleep Apnea Using Targeted Hypoglossal Neurostimulation

Clinical Trial Summary

Multi-center, open-label, prospective, randomized clinical trial of the aura6000(R) System for the reduction of apnea and hypopneas in adult patients with moderate to severe obstructive sleep apnea who have failed or are unwilling to use positive airway pressure treatment.

Clinical Trial Description

All qualifying subjects will be implanted. Subjects will be randomized 2:1 in favor of Stimulation therapy (Active Group). Randomization will occur following implant and prior to the Month 1 visit. The Active group will start Stimulation therapy at Month 1. The Control group may continue with their current sleep apnea treatment until Month 7, and will receive Stimulation therapy beginning at Month 7 +1Day. (All subjects are excluded from use of PAP or surgical treatments after enrollment through Month 13) Safety and efficacy will be evaluated at Month 7, and again at Month 13. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04950894
Study type Interventional
Source LivaNova
Contact Nadine Juran, BSN, RN
Phone 216-408-1316
Email OSPREY.Study@livanova.com
Status Recruiting
Phase N/A
Start date July 27, 2021
Completion date July 2024
View Details
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