Acoustic Coordinated Reset (CR®) Neuromodulation for the Treatment of Chronic Tonal Tinnitus ("RESET Real Life") (RRL)
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|ClinicalTrials.gov Identifier: NCT01435317|
Recruitment Status : Completed
First Posted : September 16, 2011
Last Update Posted : July 11, 2014
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Standard treatment with the ANM T30 CR®-System
Device: ANM T30 CR®-System
Stimulation for 4-6h/day for a time of 1 year
- 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.
- NRS loudness and annoyance (0-100) [ Time Frame: 0.5, 1, 2, 3, 6, 9, 12 months ]
- Tinnitus-freedom [ Time Frame: 3,6,9,12 months ]
- Compliance [ Time Frame: 0.5,1,3,6,9,12 months ]Questioning if the specified application was kept.
- 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.
- Audiogram for hearing loss change [ Time Frame: 3,12 months ]
- TBF-12 [ Time Frame: 3,6,9,12 months ]
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 ClinicalTrials.gov identifier (NCT number): NCT01435317
|Principal Investigator:||Uwe Brinkmann, Dr. med.||HNO-Gemeinschaftspraxis Hamm-Ahlen-Oelde|