Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
57 participants
INTERVENTIONAL
2013-02-28
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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aura6000 THN Therapy
The aura6000 THN system will be implanted and activated for nightly therapy during sleep.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Noncompliant to CPAP
* Willing to provide informed consent
* Willing to comply with all follow-up visits and evaluations
Exclusion Criteria
* COPD
* Central Sleep Apnea
* Anatomic variations interfering with device placement or stability.
18 Years
ALL
No
Sponsors
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ImThera Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel Rodenstein, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Clinique Univ. Saint-Luc
Ofer Jacobowitz, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hudson Valley ENT
Locations
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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
Countries
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References
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Zaidi FN, Meadows P, Jacobowitz O, Davidson TM. Tongue anatomy and physiology, the scientific basis for a novel targeted neurostimulation system designed for the treatment of obstructive sleep apnea. Neuromodulation. 2013 Jul-Aug;16(4):376-86; discussion 386. doi: 10.1111/j.1525-1403.2012.00514.x. Epub 2012 Aug 31.
Mwenge GB, Rombaux P, Dury M, Lengele B, Rodenstein D. Targeted hypoglossal neurostimulation for obstructive sleep apnoea: a 1-year pilot study. Eur Respir J. 2013 Feb;41(2):360-7. doi: 10.1183/09031936.00042412. Epub 2012 May 17.
Other Identifiers
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IMT2012-02
Identifier Type: -
Identifier Source: org_study_id
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