Targeted Hypoglossal Neurostimulation Study #2

Completed · Not applicable

Conditions studied: Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Respiration Disorders, Signs and Symptoms, Respiratory, Syndrome, Obstructive Sleep Apnea

In brief

The objective of the study is to confirm the safety and efficacy in patients utilizing the aura6000 System for the treatment of Obstructive Sleep Apnea (OSA).

Key facts

Study ID

NCT01796925

Run by

ImThera Medical, Inc.

People needed

57

Starts

2013-02-01

Expected to finish

2014-09-01

Last updated by the study team

2019-08-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• AHI >20
• Noncompliant to CPAP
• Willing to provide informed consent
• Willing to comply with all follow-up visits and evaluations

You may not qualify if…

• BMI limits
• COPD
• Central Sleep Apnea
• Anatomic variations interfering with device placement or stability.

Where it is running

• Sharp Rees Stealy Medical Center — San Diego, California, United States
• Porter Adventist Hospital — Denver, Colorado, United States
• Chicago ENT — Chicago, Illinois, United States
• Orange Regional Medical Center — Middletown, New York, United States
• Clinique Univ. Saint-Luc — Brussels, Belgium
• Pitié-Salpêtrière Hospital — Paris, France
• Advanced Sleep Research — Berlin, Germany
• St. Joseph-Stift — Bremen, Germany
• G.B. Morgagni- L. Pierantoni Hospital — Forlì, Italy

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.