Targeted Hypoglossal Neurostimulation Study #3



Status:Active, not recruiting
Conditions:Insomnia Sleep Studies, Pulmonary
Therapuetic Areas:Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:3/1/2019
Start Date:February 2015
End Date:December 2022

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ImThera Medical Targeted Hypoglossal Neurostimulation Study #3

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.

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.

Inclusion Criteria:

- Age >18 years

- Individual has failed or does not tolerate PAP therapy

- Has failed or refuses alternative OSA treatments (e.g.surgery, oral appliances, and
behavioral treatments)

- AHI ≥ 20 (Moderate to severe OSA)

Exclusion Critera:

- Implanted with another active implantable device

- Body mass index (BMI) ≥ 35 kg/m²
We found this trial at
20
sites
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Principal Investigator: Alan R Schwartz, MD
Phone: 410-550-4588
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
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3500 Camp Bowie Boulevard
Fort Worth, Texas 76107
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Atlanta, Georgia 30342
Principal Investigator: Samuel A Mickelson, MD
Phone: 404-943-0900
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Atlanta, GA
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Austin, Texas 78731
Principal Investigator: John D. Hudson, MD
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Austin, TX
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Boca Raton, Florida 33487
Principal Investigator: Nathan Nachlas, MD
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Boca Raton, FL
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Brussels,
Principal Investigator: Philippe Rombaux, MD, PhD
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Brussels,
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12188A North Meridian Street
Carmel, Indiana 46032
Principal Investigator: Tod Huntley, MD
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Carmel, IN
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Neskey David, MD
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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765 Medical Center Court
Chula Vista, California 91911
Principal Investigator: Paul Schalch, MD
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Chula Vista, CA
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Cincinnati, Ohio 45245
Principal Investigator: Bruce Corser, MD
Phone: 513-977-8891
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Cincinnati, OH
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Columbus, Ohio 43017
Principal Investigator: Asim Roy, MD
Phone: 614-766-0773
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Columbus, OH
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Long Beach, California 90801
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Los Angeles, California 90048
Principal Investigator: Martin L Hopp, MD, PhD
Phone: 310-657-2253
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Louisville, Kentucky 40217
Principal Investigator: David H Winslow, MD
Phone: 502-479-1217
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1325 Eastmoreland Avenue
Memphis, Tennessee 38104
Principal Investigator: Marion B Gillespie, MD
Phone: 901-448-2284
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New York, New York 10016
Principal Investigator: Ofer Jacobowitz, MD, PhD
Phone: 845-562-5941
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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7901 Frost Street
San Diego, California 92123
858-939-3400
Sharp Memorial Hospital Sharp Memorial Hospital offers clinical excellence with the latest technology and patient-centered...
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San Diego, California 92120
Principal Investigator: Brian Weeks, MD
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Tampa, Florida 33607
Principal Investigator: Mitchell Miller, MD
Phone: 727-725-6455
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