138
Participants
Start Date
February 28, 2015
Primary Completion Date
June 30, 2019
Study Completion Date
September 1, 2023
aura6000 System
The aura6000 System is intended to unilaterally stimulate the hypoglossal nerve which innervates the muscles of the tongue. The aura6000 System stimulates the hypoglossal nerve cyclically and continuously during sleep to maintain muscle tone of the tongue and upper airway during sleep. Stimulation is generated by a programmable, multi-current source, implantable neurostimulator (IPG) and delivered to the hypoglossal nerve by a lead with multi-contact cuff electrode (lead).
Clinique Univ. Saint-Luc, Brussels
ENT and Allergy Associates, New York
Johns Hopkins University, Baltimore
Medical University of South Carolina, Charleston
Advanced ENT Asociates, Atlanta
Ear, Nose, and Throat Associates of South Florida, Boca Raton
Morton Plant Mease Healthcare, Safety Harbor
UT Methodist Physicians, Memphis
Kentucky Research Group, Louisville
Intrepid Research, Cincinnati
Center for ENT and Allergy, Carmel
Pitie Salpetriere, Paris
FutureSearch Trials, Austin
Tower ENT, Los Angeles
ENT Associates of San Diego, Chula Vista
SENTA Clinic, San Diego
Foch Hospital, Suresnes
Ruprechts-Karls University, Mannheim
Bnai Zion Medical Center, Haifa
Hospital CUF Porto, Porto
Lead Sponsor
Collaborators (1)
LivaNova
INDUSTRY
ImThera Medical, Inc.
INDUSTRY