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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01435317
Recruitment Status : Completed
First Posted : September 16, 2011
Last Update Posted : July 11, 2014
Information provided by (Responsible Party):
ANM Adaptive Neuromodulation GmbH

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

Condition or disease Intervention/treatment Phase
Tinnitus Device: ANM T30 CR®-System Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  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 [ Time Frame: 0.5,1,3,6,9,12 months ]
    Questioning if the specified application was kept.

  4. 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.

  5. Audiogram for hearing loss change [ Time Frame: 3,12 months ]
  6. TBF-12 [ Time Frame: 3,6,9,12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01435317

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Sponsors and Collaborators
ANM Adaptive Neuromodulation GmbH
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Principal Investigator: Uwe Brinkmann, Dr. med. HNO-Gemeinschaftspraxis Hamm-Ahlen-Oelde
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Responsible Party: ANM Adaptive Neuromodulation GmbH Identifier: NCT01435317    
Other Study ID Numbers: NCT2011-08-26
First Posted: September 16, 2011    Key Record Dates
Last Update Posted: July 11, 2014
Last Verified: July 2014
Keywords provided by ANM Adaptive Neuromodulation GmbH:
Acoustic CR®-neuromodulation
ANM T30 CR®-System
Additional relevant MeSH terms:
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Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases