Acoustic Coordinated Reset (CR®) Neuromodulation for the Treatment of Chronic Tonal Tinnitus ("RESET Real Life")
NCT ID: NCT01435317
Last Updated: 2014-07-11
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
PHASE4
200 participants
INTERVENTIONAL
2011-11-30
2014-07-31
Brief Summary
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* Identification of early indicators for therapy success
* Comparison of different patient groups regarding: tinnitus severity, tinnitus duration, level of hearing loss, stimulation patterns, unilateral monotonal vs. all other complex forms
* Representative set of safety data in a broad patient spectrum
* Measurement of tinnitus burden (TBF-12 Questionnaire)
* Generation of longterm compliance data
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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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standard
Standard treatment with the ANM T30 CR®-System
ANM T30 CR®-System
Stimulation for 4-6h/day for a time of 1 year
Interventions
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ANM T30 CR®-System
Stimulation for 4-6h/day for a time of 1 year
Eligibility Criteria
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Inclusion Criteria
* \<60dB hearing loss
* men and women ≥18 years old
Exclusion Criteria
* psychiatric or internistic disease
* objective tinnitus
* Morbus Menière
* craniomandibular triggered tinnitus
18 Years
ALL
No
Sponsors
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CERES GmbH
INDUSTRY
ANM Adaptive Neuromodulation GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Uwe Brinkmann, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
HNO-Gemeinschaftspraxis Hamm-Ahlen-Oelde
Locations
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Dr. med. Mueller
Augsburg, , Germany
Dr. med. Jan Loehler
Bad Bramstedt, , Germany
Praxisverbund Berlin
Berlin, , Germany
Dr. med. Daniel Osterland
Berlin, , Germany
Dres. med. Bodlien/Lingner/Kassuhn
Braunschweig, , Germany
Praxis HNO Koeln Nord
Cologne, , Germany
Dres. Lindenberger Wilhelm Ecke Elies Sperl Brackmann
Frankfurt, , Germany
Dr. med. Fleissner
Freiburg im Breisgau, , Germany
EuromedClinic
Fürth, , Germany
Dr. med. Hegemann-Gaertner
Grevenbroich, , Germany
Dipl.-Med. Kathrin Stoelzer
Halle, , Germany
Dr. med. Hahbrock
Koblenz, , Germany
Dr. med. Wichmann
Krefeld, , Germany
Roemerwallklini Gmbh
Mainz, , Germany
HNO-Gemeinschaftspraxis im Zentrum
Mannheim, , Germany
Dr .med. Tatjana von Stackelberg
Meerbusch, , Germany
Dr. med. Ullmann
Melsungen, , Germany
Dr. med. Wurzer
München, , Germany
Dres. med. Bergmann und Davies
Nürtingen, , Germany
Dr. med Uwe Brinkmann
Oelde, , Germany
Dr. med. Huegelschaeffer
Philippsburg, , Germany
Dr. med. Axel Roesler
Radevormwald, , Germany
Dres. med. Ramming und Waller
Schweinfurt, , Germany
Countries
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Other Identifiers
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NCT2011-08-26
Identifier Type: -
Identifier Source: org_study_id
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