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

This study has been completed.
Sponsor:
Collaborator:
Ceres GmbH evaluation & research
Information provided by (Responsible Party):
ANM Adaptive Neuromodulation GmbH
ClinicalTrials.gov Identifier:
NCT01435317
First received: August 31, 2011
Last updated: July 10, 2014
Last verified: July 2014

August 31, 2011
July 10, 2014
November 2011
June 2013   (final data collection date for primary outcome measure)
Improvement of TBF-12 Score or CGI Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Change of tinnitus severity, measured by TBF-12 Score or CGI score change from baseline to end of treatment.
Same as current
Complete list of historical versions of study NCT01435317 on ClinicalTrials.gov Archive Site
  • NRS loudness and annoyance (0-100) [ Time Frame: 0.5, 1, 2, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • Tinnitus-freedom [ Time Frame: 3,6,9,12 months ] [ Designated as safety issue: No ]
  • Compliance [ Time Frame: 0.5,1,3,6,9,12 months ] [ Designated as safety issue: No ]
    Questioning if the specified application was kept.
  • Alteration of tinnitus [ Time Frame: 0.5,1,2,3,6,9,12 months ] [ Designated as safety issue: No ]
    Early alteration of tinnitus frequency and psychometric tinnitus loudness, measured with the ANM T30 CR®-System.
  • Audiogram for hearing loss change [ Time Frame: 3,12 months ] [ Designated as safety issue: No ]
  • TBF-12 [ Time Frame: 3,6,9,12 months ] [ Designated as safety issue: No ]
  • VAS loudness and annoyance (0-100) - 1° at each visit [ Time Frame: 0.5, 1, 2, 3, 6, 9, 12 months ] [ Designated as safety issue: No ]
  • Tinnitus-freedom [ Time Frame: 3,6,9,12 months ] [ Designated as safety issue: No ]
  • Compliance [ Time Frame: 0.5,1,3,6,9,12 months ] [ Designated as safety issue: No ]
    Questioning if the specified application was kept.
  • Alteration of tinnitus [ Time Frame: 0.5,1,2,3,6,9,12 months ] [ Designated as safety issue: No ]
    Early alteration of tinnitus frequency and psychometric tinnitus loudness, measured with the ANM T30 CR®-System.
  • Audiogram for hearing loss change [ Time Frame: 3,12 months ] [ Designated as safety issue: No ]
  • TBF-12 [ Time Frame: 3,6,9,12 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Acoustic Coordinated Reset (CR®) Neuromodulation for the Treatment of Chronic Tonal Tinnitus ("RESET Real Life")
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
Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Tinnitus
Device: ANM T30 CR®-System
Stimulation for 4-6h/day for a time of 1 year
Other Name: ANM T30 CR®-System
Experimental: standard
Standard treatment with the ANM T30 CR®-System
Intervention: Device: ANM T30 CR®-System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
July 2014
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01435317
NCT2011-08-26
Yes
ANM Adaptive Neuromodulation GmbH
ANM Adaptive Neuromodulation GmbH
Ceres GmbH evaluation & research
Principal Investigator: Uwe Brinkmann, Dr. med. HNO-Gemeinschaftspraxis Hamm-Ahlen-Oelde
ANM Adaptive Neuromodulation GmbH
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP