Targeted Hypoglossal Neurostimulation Study #2



Status:Completed
Conditions:Insomnia Sleep Studies, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:10/3/2013
Start Date:February 2013
End Date:April 2014

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Clinical Study of the aura6000™ Targeted Hypoglossal Implantable Neurostimulation (THN) Sleep Therapy System


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).


Inclusion Criteria:

- AHI >20

- Noncompliant to CPAP

- Willing to provide informed consent

- Willing to comply with all follow-up visits and evaluations

Exclusion Criteria:

- BMI limits

- COPD

- Central Sleep Apnea

- Anatomic variations interfering with device placement or stability.
We found this trial at
3
sites
Chicago, Illinois 60657
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2525 S Downing St
Denver, Colorado 80210
(303) 778-1955
Porter Adventist Hospital Founded in 1930, Porter Adventist Hospital has provided people throughout Denver and...
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Denver, CO
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Middletown, New York 10940
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Middletown, NY
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