Safety and Efficacy of a Hypoglossal Nerve Implant for the Treatment of Obstructive Sleep Apnea (OSA)

NACompletedINTERVENTIONAL
Enrollment

14

Participants

Timeline

Start Date

November 30, 2009

Primary Completion Date

December 31, 2011

Study Completion Date

December 31, 2011

Conditions
Sleep Apnea SyndromesSleep Apnea, ObstructiveRespiration DisordersSigns and Symptoms, RespiratorySyndrome, Obstructive Sleep Apnea
Interventions
DEVICE

aura6000 System

The aura6000 device is an implanted hypoglossal nerve stimulator designed to maintain wakeful muscle tone of the tongue during sleep. It is implanted through a short surgical procedure. The implant is programmed to provide the optimal stimulation parameters for the patient. The therapy is controlled by a hand-held remote control allowing the patient to start, stop, and pause the therapy during times of sleep.

Trial Locations (1)

1200

Clinique Univ. Saint-Luc, Brussels

Sponsors
All Listed Sponsors
lead

ImThera Medical, Inc.

INDUSTRY