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Targeted Hypoglossal Neurostimulation Study #3 — THN3  

Obstructive Sleep Apnea Clinical Trial

Official title:
ImThera Medical Targeted Hypoglossal Neurostimulation Study #3

Clinical Trial Summary

The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the ImThera Medical aura6000 System as a potential therapeutic option for individuals with moderate to severe OSA that have failed or do not tolerate PAP.

Clinical Trial Description

The objectives of this study are to evaluate the safety and effectiveness of the aura6000 System for the treatment of moderate to severe obstructive sleep apnea (OSA) in individuals who have failed or do not tolerate positive airway pressure (PAP) therapy or have failed or are intolerant of or refuse indicated alternative OSA treatments (such as oral appliances, positional devices and conventional sleep surgeries). PAP failure is defined as an inability to eliminate OSA (AHI > 20 despite PAP usage) and PAP intolerance is defined as: 1) inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night); or 2) unwillingness to use PAP (for example, a patient returns the PAP system after attempting to use it). The results of this study are anticipated to provide reasonable assurance of the safety and effectiveness of the aura6000 System when used as intended and to support the application for FDA Premarket Approval of the system. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02263859
Study type Interventional
Source LivaNova
Contact
Status Completed
Phase N/A
Start date February 2015
Completion date September 1, 2023
View Details
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