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

Primary Purpose

Tinnitus

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
ANM T30 CR®-System
Sponsored by
ANM Adaptive Neuromodulation GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Acoustic CR®-neuromodulation, ANM T30 CR®-System

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dr. med. Mueller
  • Dr. med. Jan Loehler
  • Praxisverbund Berlin
  • Dr. med. Daniel Osterland
  • Dres. med. Bodlien/Lingner/Kassuhn
  • Dres. Lindenberger Wilhelm Ecke Elies Sperl Brackmann
  • Dr. med. Fleissner
  • EuromedClinic
  • Dr. med. Hegemann-Gaertner
  • Dipl.-Med. Kathrin Stoelzer
  • Dr. med. Hahbrock
  • Praxis HNO Koeln Nord
  • Dr. med. Wichmann
  • Roemerwallklini Gmbh
  • HNO-Gemeinschaftspraxis im Zentrum
  • Dr .med. Tatjana von Stackelberg
  • Dr. med. Ullmann
  • Dr. med. Wurzer
  • Dres. med. Bergmann und Davies
  • Dr. med Uwe Brinkmann
  • Dr. med. Huegelschaeffer
  • Dr. med. Axel Roesler
  • Dres. med. Ramming und Waller

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

standard

Arm Description

Standard treatment with the ANM T30 CR®-System

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

NRS loudness and annoyance (0-100)
Tinnitus-freedom
Compliance
Questioning if the specified application was kept.
Alteration of tinnitus
Early alteration of tinnitus frequency and psychometric tinnitus loudness, measured with the ANM T30 CR®-System.
Audiogram for hearing loss change
TBF-12

Full Information

First Posted
August 31, 2011
Last Updated
July 10, 2014
Sponsor
ANM Adaptive Neuromodulation GmbH
Collaborators
CERES GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01435317
Brief Title
Acoustic Coordinated Reset (CR®) Neuromodulation for the Treatment of Chronic Tonal Tinnitus ("RESET Real Life")
Acronym
RRL
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ANM Adaptive Neuromodulation GmbH
Collaborators
CERES GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Acoustic CR®-neuromodulation, ANM T30 CR®-System

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
standard
Arm Type
Experimental
Arm Description
Standard treatment with the ANM T30 CR®-System
Intervention Type
Device
Intervention Name(s)
ANM T30 CR®-System
Intervention Description
Stimulation for 4-6h/day for a time of 1 year
Primary Outcome Measure Information:
Title
Improvement of TBF-12 Score or CGI Score
Description
Change of tinnitus severity, measured by TBF-12 Score or CGI score change from baseline to end of treatment.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
NRS loudness and annoyance (0-100)
Time Frame
0.5, 1, 2, 3, 6, 9, 12 months
Title
Tinnitus-freedom
Time Frame
3,6,9,12 months
Title
Compliance
Description
Questioning if the specified application was kept.
Time Frame
0.5,1,3,6,9,12 months
Title
Alteration of tinnitus
Description
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
Title
Audiogram for hearing loss change
Time Frame
3,12 months
Title
TBF-12
Time Frame
3,6,9,12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uwe Brinkmann, Dr. med.
Organizational Affiliation
HNO-Gemeinschaftspraxis Hamm-Ahlen-Oelde
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. med. Mueller
City
Augsburg
ZIP/Postal Code
86167
Country
Germany
Facility Name
Dr. med. Jan Loehler
City
Bad Bramstedt
ZIP/Postal Code
24576
Country
Germany
Facility Name
Praxisverbund Berlin
City
Berlin
ZIP/Postal Code
10119
Country
Germany
Facility Name
Dr. med. Daniel Osterland
City
Berlin
ZIP/Postal Code
10711
Country
Germany
Facility Name
Dres. med. Bodlien/Lingner/Kassuhn
City
Braunschweig
ZIP/Postal Code
38100
Country
Germany
Facility Name
Dres. Lindenberger Wilhelm Ecke Elies Sperl Brackmann
City
Frankfurt
ZIP/Postal Code
60594
Country
Germany
Facility Name
Dr. med. Fleissner
City
Freiburg
ZIP/Postal Code
79098
Country
Germany
Facility Name
EuromedClinic
City
Fuerth
ZIP/Postal Code
90763
Country
Germany
Facility Name
Dr. med. Hegemann-Gaertner
City
Grevenbroich
ZIP/Postal Code
41515
Country
Germany
Facility Name
Dipl.-Med. Kathrin Stoelzer
City
Halle/Saale
ZIP/Postal Code
06108
Country
Germany
Facility Name
Dr. med. Hahbrock
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
Praxis HNO Koeln Nord
City
Koeln
ZIP/Postal Code
50735
Country
Germany
Facility Name
Dr. med. Wichmann
City
Krefeld
ZIP/Postal Code
47807
Country
Germany
Facility Name
Roemerwallklini Gmbh
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
HNO-Gemeinschaftspraxis im Zentrum
City
Mannheim
ZIP/Postal Code
68161
Country
Germany
Facility Name
Dr .med. Tatjana von Stackelberg
City
Meerbusch
ZIP/Postal Code
40667
Country
Germany
Facility Name
Dr. med. Ullmann
City
Melsungen
ZIP/Postal Code
34212
Country
Germany
Facility Name
Dr. med. Wurzer
City
Muenchen
ZIP/Postal Code
80333
Country
Germany
Facility Name
Dres. med. Bergmann und Davies
City
Nuertingen
ZIP/Postal Code
72622
Country
Germany
Facility Name
Dr. med Uwe Brinkmann
City
Oelde
ZIP/Postal Code
59302
Country
Germany
Facility Name
Dr. med. Huegelschaeffer
City
Philippsburg
ZIP/Postal Code
76661
Country
Germany
Facility Name
Dr. med. Axel Roesler
City
Radevormwald
ZIP/Postal Code
42477
Country
Germany
Facility Name
Dres. med. Ramming und Waller
City
Schweinfurt
ZIP/Postal Code
97421
Country
Germany

12. IPD Sharing Statement

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

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