Targeted Hypoglossal Neurostimulation Study #2

NACompletedINTERVENTIONAL
Enrollment

57

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

September 30, 2013

Study Completion Date

September 30, 2014

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

aura6000 THN 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 (9)

1200

Clinique Univ. Saint-Luc, Brussels

10117

Advanced Sleep Research, Berlin

10940

Orange Regional Medical Center, Middletown

28209

St. Joseph-Stift, Bremen

47121

G.B. Morgagni- L. Pierantoni Hospital, Forlì

60657

Chicago ENT, Chicago

75013

Pitié-Salpêtrière Hospital, Paris

80210

Porter Adventist Hospital, Denver

92123

Sharp Rees Stealy Medical Center, San Diego

Sponsors
All Listed Sponsors
lead

ImThera Medical, Inc.

INDUSTRY

NCT01796925 - Targeted Hypoglossal Neurostimulation Study #2 | Biotech Hunter | Biotech Hunter