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CompletedNCT01435317RRLUpdated Jul 11, 2014

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

A Phase 4 interventional study of ANM T30 CR®-System in Tinnitus, sponsored by ANM Adaptive Neuromodulation GmbH. Completed at 23 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-11.

Sponsored by ANM Adaptive Neuromodulation GmbH · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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
02

Conditions studied

  • Tinnitus

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Keywords

  • Acoustic CR®-neuromodulation
  • ANM T30 CR®-System
03

In context

Tinnitus

412 studies on the registry are indexed under Tinnitus; 87 are open to participants now.

This study's enrollment of 200 is above the median of 60 across 339 interventional studies indexed under Tinnitus.

Browse Tinnitus studies →

Lead sponsor

ANM Adaptive Neuromodulation GmbH is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    standard

    Standard treatment with the ANM T30 CR®-System

    Device: ANM T30 CR®-System

Interventions

  • DeviceANM T30 CR®-System

    Stimulation for 4-6h/day for a time of 1 year

06

What researchers measure

Primary outcomes

  1. Improvement of TBF-12 Score or CGI Score

    Change of tinnitus severity, measured by TBF-12 Score or CGI score change from baseline to end of treatment.

    Time frame: 12 months

Secondary outcomes

  1. NRS loudness and annoyance (0-100)

    Time frame: 0.5, 1, 2, 3, 6, 9, 12 months

  2. Tinnitus-freedom

    Time frame: 3,6,9,12 months

  3. Compliance

    Questioning if the specified application was kept.

    Time frame: 0.5,1,3,6,9,12 months

  4. Alteration of tinnitus

    Early alteration of tinnitus frequency and psychometric tinnitus loudness, measured with the ANM T30 CR®-System.

    Time frame: 0.5,1,2,3,6,9,12 months

  5. Audiogram for hearing loss change

    Time frame: 3,12 months

  6. TBF-12

    Time frame: 3,6,9,12 months

07

Study locations

23 sites
  • Dr. med. Mueller
    Augsburg, 86167, Germany
  • Dr. med. Jan Loehler
    Bad Bramstedt, 24576, Germany
  • Praxisverbund Berlin
    Berlin, 10119, Germany
  • Dr. med. Daniel Osterland
    Berlin, 10711, Germany
  • Dres. med. Bodlien/Lingner/Kassuhn
    Braunschweig, 38100, Germany
  • Dres. Lindenberger Wilhelm Ecke Elies Sperl Brackmann
    Frankfurt, 60594, Germany
  • Dr. med. Fleissner
    Freiburg, 79098, Germany
  • EuromedClinic
    Fuerth, 90763, Germany
  • Dr. med. Hegemann-Gaertner
    Grevenbroich, 41515, Germany
  • Dipl.-Med. Kathrin Stoelzer
    Halle/Saale, 06108, Germany
  • Dr. med. Hahbrock
    Koblenz, 56068, Germany
  • Praxis HNO Koeln Nord
    Koeln, 50735, Germany
  • Dr. med. Wichmann
    Krefeld, 47807, Germany
  • Roemerwallklini Gmbh
    Mainz, 55131, Germany
  • HNO-Gemeinschaftspraxis im Zentrum
    Mannheim, 68161, Germany
  • Dr .med. Tatjana von Stackelberg
    Meerbusch, 40667, Germany
  • Dr. med. Ullmann
    Melsungen, 34212, Germany
  • Dr. med. Wurzer
    Muenchen, 80333, Germany
  • Dres. med. Bergmann und Davies
    Nuertingen, 72622, Germany
  • Dr. med Uwe Brinkmann
    Oelde, 59302, Germany
  • Dr. med. Huegelschaeffer
    Philippsburg, 76661, Germany
  • Dr. med. Axel Roesler
    Radevormwald, 42477, Germany
  • Dres. med. Ramming und Waller
    Schweinfurt, 97421, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01435317
Lead sponsor
ANM Adaptive Neuromodulation GmbH
Collaborators
CERES GmbH
Responsible party
Sponsor
First posted
Sep 16, 2011
Start date
Nov 2011
Primary completion
Jun 2013
Completion
Jul 2014
Last update
Jul 11, 2014

Study contacts

Uwe Brinkmann, Dr. med.
principal investigator · HNO-Gemeinschaftspraxis Hamm-Ahlen-Oelde

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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