Acoustic Coordinated Reset (CR®) Neuromodulation for the Treatment of Chronic Tonal Tinnitus ("RESET Real Life")

Last updated: July 10, 2014
Sponsor: ANM Adaptive Neuromodulation GmbH
Overall Status: Completed

Phase

4

Condition

Tinnitus

Treatment

N/A

Clinical Study ID

NCT01435317
NCT2011-08-26
  • Ages > 18
  • All Genders

Study Summary

Confirmation of efficacy and safety of acoustic CR®-neuromodulation for the treatment of chronic tinnitus patients using the CE marked ANM T30 CR®-system in a real life outpatient setting.

  • 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

Eligibility Criteria

Inclusion

Main Inclusion Criteria:

  • symptomatic subjective tonal chronical (> 3 months) tinnitus

  • <60dB hearing loss

  • men and women ≥18 years old

Exclusion

Main Exclusion Criteria:

  • serious neurologic

  • psychiatric or internistic disease

  • objective tinnitus

  • Morbus Menière

  • craniomandibular triggered tinnitus

Study Design

Total Participants: 200
Study Start date:
November 01, 2011
Estimated Completion Date:
July 31, 2014

Connect with a study center

  • Dr. med. Mueller

    Augsburg, 86167
    Germany

    Site Not Available

  • Dr. med. Jan Loehler

    Bad Bramstedt, 24576
    Germany

    Site Not Available

  • Dr. med. Daniel Osterland

    Berlin, 10711
    Germany

    Site Not Available

  • Praxisverbund Berlin

    Berlin, 10119
    Germany

    Site Not Available

  • Dres. med. Bodlien/Lingner/Kassuhn

    Braunschweig, 38100
    Germany

    Site Not Available

  • Dres. Lindenberger Wilhelm Ecke Elies Sperl Brackmann

    Frankfurt, 60594
    Germany

    Site Not Available

  • Dr. med. Fleissner

    Freiburg, 79098
    Germany

    Site Not Available

  • EuromedClinic

    Fuerth, 90763
    Germany

    Site Not Available

  • Dr. med. Hegemann-Gaertner

    Grevenbroich, 41515
    Germany

    Site Not Available

  • Dipl.-Med. Kathrin Stoelzer

    Halle/Saale, 06108
    Germany

    Site Not Available

  • Dr. med. Beyer-Niesen

    Hamburg, 22179
    Germany

    Site Not Available

  • Dr. med. Hahbrock

    Koblenz, 56068
    Germany

    Site Not Available

  • Praxis HNO Koeln Nord

    Koeln, 50735
    Germany

    Site Not Available

  • Dr. med. Wichmann

    Krefeld, 47807
    Germany

    Site Not Available

  • Roemerwallklini Gmbh

    Mainz, 55131
    Germany

    Site Not Available

  • HNO-Gemeinschaftspraxis im Zentrum

    Mannheim, 68161
    Germany

    Site Not Available

  • Dr .med. Tatjana von Stackelberg

    Meerbusch, 40667
    Germany

    Site Not Available

  • Dr. med. Ullmann

    Melsungen, 34212
    Germany

    Site Not Available

  • Dr. med. Wurzer

    Muenchen, 80333
    Germany

    Site Not Available

  • Dres. med. Bergmann und Davies

    Nuertingen, 72622
    Germany

    Site Not Available

  • Dr. med Uwe Brinkmann

    Oelde, 59302
    Germany

    Site Not Available

  • Dr. med. Huegelschaeffer

    Philippsburg, 76661
    Germany

    Site Not Available

  • Dr. med. Axel Roesler

    Radevormwald, 42477
    Germany

    Site Not Available

  • Hospital of the University of Regensburg

    Regensburg, 93053
    Germany

    Site Not Available

  • Dres. med. Ramming und Waller

    Schweinfurt, 97421
    Germany

    Site Not Available

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