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

July 10, 2014 updated by: ANM Adaptive Neuromodulation GmbH

Prospective Clinical Study for Confirmation of Efficacy and Safety of Acoustic CR®-Neuromodulation by CE Marked ANM T30 CR®-System in a "Real Life" Patient Population With Chronic Tonal Tinnitus

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Augsburg, Germany, 86167
        • Dr. med. Mueller
      • Bad Bramstedt, Germany, 24576
        • Dr. med. Jan Loehler
      • Berlin, Germany, 10119
        • Praxisverbund Berlin
      • Berlin, Germany, 10711
        • Dr. med. Daniel Osterland
      • Braunschweig, Germany, 38100
        • Dres. med. Bodlien/Lingner/Kassuhn
      • Frankfurt, Germany, 60594
        • Dres. Lindenberger Wilhelm Ecke Elies Sperl Brackmann
      • Freiburg, Germany, 79098
        • Dr. med. Fleissner
      • Fuerth, Germany, 90763
        • EuromedClinic
      • Grevenbroich, Germany, 41515
        • Dr. med. Hegemann-Gaertner
      • Halle/Saale, Germany, 06108
        • Dipl.-Med. Kathrin Stoelzer
      • Koblenz, Germany, 56068
        • Dr. med. Hahbrock
      • Koeln, Germany, 50735
        • Praxis HNO Koeln Nord
      • Krefeld, Germany, 47807
        • Dr. med. Wichmann
      • Mainz, Germany, 55131
        • Roemerwallklini Gmbh
      • Mannheim, Germany, 68161
        • HNO-Gemeinschaftspraxis im Zentrum
      • Meerbusch, Germany, 40667
        • Dr .med. Tatjana von Stackelberg
      • Melsungen, Germany, 34212
        • Dr. med. Ullmann
      • Muenchen, Germany, 80333
        • Dr. med. Wurzer
      • Nuertingen, Germany, 72622
        • Dres. med. Bergmann und Davies
      • Oelde, Germany, 59302
        • Dr. med Uwe Brinkmann
      • Philippsburg, Germany, 76661
        • Dr. med. Huegelschaeffer
      • Radevormwald, Germany, 42477
        • Dr. med. Axel Roesler
      • Schweinfurt, Germany, 97421
        • Dres. med. Ramming und Waller

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Main Inclusion Criteria:

  • symptomatic subjective tonal chronical (> 3 months) tinnitus
  • <60dB hearing loss
  • men and women ≥18 years old

Main Exclusion Criteria:

  • serious neurologic
  • psychiatric or internistic disease
  • objective tinnitus
  • Morbus Menière
  • craniomandibular triggered tinnitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: standard
Standard treatment with the ANM T30 CR®-System
Device: ANM T30 CR®-System
Stimulation for 4-6h/day for a time of 1 year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of TBF-12 Score or CGI Score
Time Frame: 12 months
Change of tinnitus severity, measured by TBF-12 Score or CGI score change from baseline to end of treatment.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NRS loudness and annoyance (0-100)
Time Frame: 0.5, 1, 2, 3, 6, 9, 12 months
0.5, 1, 2, 3, 6, 9, 12 months
Tinnitus-freedom
Time Frame: 3,6,9,12 months
3,6,9,12 months
Compliance
Time Frame: 0.5,1,3,6,9,12 months
Questioning if the specified application was kept.
0.5,1,3,6,9,12 months
Alteration of tinnitus
Time Frame: 0.5,1,2,3,6,9,12 months
Early alteration of tinnitus frequency and psychometric tinnitus loudness, measured with the ANM T30 CR®-System.
0.5,1,2,3,6,9,12 months
Audiogram for hearing loss change
Time Frame: 3,12 months
3,12 months
TBF-12
Time Frame: 3,6,9,12 months
3,6,9,12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANM Adaptive Neuromodulation GmbH

Collaborators

CERES GmbH

Investigators

  • Principal Investigator: Uwe Brinkmann, Dr. med., HNO-Gemeinschaftspraxis Hamm-Ahlen-Oelde

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

August 31, 2011

First Submitted That Met QC Criteria

September 15, 2011

First Posted (Estimate)

September 16, 2011

Study Record Updates

Last Update Posted (Estimate)

July 11, 2014

Last Update Submitted That Met QC Criteria

July 10, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCT2011-08-26

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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