NCT01435317

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2011

Typical duration for phase_4

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2011

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 16, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

July 11, 2014

Status Verified

July 1, 2014

Enrollment Period

1.6 years

First QC Date

August 31, 2011

Last Update Submit

July 10, 2014

Conditions

Tinnitus

Keywords

Acoustic CR®-neuromodulationANM T30 CR®-System

Outcome Measures

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.

    12 months

Secondary Outcomes (6)

  • NRS loudness and annoyance (0-100)

    0.5, 1, 2, 3, 6, 9, 12 months

  • Tinnitus-freedom

    3,6,9,12 months

  • Compliance

    0.5,1,3,6,9,12 months

  • Alteration of tinnitus

    0.5,1,2,3,6,9,12 months

  • Audiogram for hearing loss change

    3,12 months

  • +1 more secondary outcomes

Study Arms (1)

standard

EXPERIMENTAL

Standard treatment with the ANM T30 CR®-System

Device: ANM T30 CR®-System

Interventions

ANM T30 CR®-SystemDEVICE

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

standard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Dr. med. Mueller

Augsburg, 86167, Germany

Location

Dr. med. Jan Loehler

Bad Bramstedt, 24576, Germany

Location

Praxisverbund Berlin

Berlin, 10119, Germany

Location

Dr. med. Daniel Osterland

Berlin, 10711, Germany

Location

Dres. med. Bodlien/Lingner/Kassuhn

Braunschweig, 38100, Germany

Location

Praxis HNO Koeln Nord

Cologne, 50735, Germany

Location

Dres. Lindenberger Wilhelm Ecke Elies Sperl Brackmann

Frankfurt, 60594, Germany

Location

Dr. med. Fleissner

Freiburg im Breisgau, 79098, Germany

Location

EuromedClinic

Fürth, 90763, Germany

Location

Dr. med. Hegemann-Gaertner

Grevenbroich, 41515, Germany

Location

Dipl.-Med. Kathrin Stoelzer

Halle, 06108, Germany

Location

Dr. med. Hahbrock

Koblenz, 56068, Germany

Location

Dr. med. Wichmann

Krefeld, 47807, Germany

Location

Roemerwallklini Gmbh

Mainz, 55131, Germany

Location

HNO-Gemeinschaftspraxis im Zentrum

Mannheim, 68161, Germany

Location

Dr .med. Tatjana von Stackelberg

Meerbusch, 40667, Germany

Location

Dr. med. Ullmann

Melsungen, 34212, Germany

Location

Dr. med. Wurzer

München, 80333, Germany

Location

Dres. med. Bergmann und Davies

Nürtingen, 72622, Germany

Location

Dr. med Uwe Brinkmann

Oelde, 59302, Germany

Location

Dr. med. Huegelschaeffer

Philippsburg, 76661, Germany

Location

Dr. med. Axel Roesler

Radevormwald, 42477, Germany

Location

Dres. med. Ramming und Waller

Schweinfurt, 97421, Germany

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Uwe Brinkmann, Dr. med.

    HNO-Gemeinschaftspraxis Hamm-Ahlen-Oelde

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2011

First Posted

September 16, 2011

Study Start

November 1, 2011

Primary Completion

June 1, 2013

Study Completion

July 1, 2014

Last Updated

July 11, 2014

Record last verified: 2014-07

Locations

DE(23)