Acoustic Coordinated Reset (CR®) Neuromodulation for the Treatment of Chronic Tonal Tinnitus ("RESET Real Life") (RRL)
This study is ongoing, but not recruiting participants.
Sponsor:
ANM Adaptive Neuromodulation GmbH
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: April 4, 2012
Last verified: April 2012
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Tinnitus |
Device: ANM T30 CR®-System |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by ANM Adaptive Neuromodulation GmbH:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 200 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
Other Name: ANM T30 CR®-System
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435317
Locations
| Germany | |
| Dr. med. Mueller | |
| Augsburg, Germany, 86167 | |
| Dr. med. Jan Loehler | |
| Bad Bramstedt, Germany, 24576 | |
| Praxisverbund Berlin | |
| Berlin, Germany, 10119 | |
| Dr. med. Daniel Osterland | |
| Berlin, Germany, 10711 | |
| Dres. med. Bodlien/Lingner/Kassuhn | |
| Braunschweig, Germany, 38100 | |
| Dres. Lindenberger Wilhelm Ecke Elies Sperl Brackmann | |
| Frankfurt, Germany, 60594 | |
| Dr. med. Fleissner | |
| Freiburg, Germany, 79098 | |
| EuromedClinic | |
| Fuerth, Germany, 90763 | |
| Dr. med. Hegemann-Gaertner | |
| Grevenbroich, Germany, 41515 | |
| Dipl.-Med. Kathrin Stoelzer | |
| Halle/Saale, Germany, 06108 | |
| Dr. med. Hahbrock | |
| Koblenz, Germany, 56068 | |
| Praxis HNO Koeln Nord | |
| Koeln, Germany, 50735 | |
| Dr. med. Wichmann | |
| Krefeld, Germany, 47807 | |
| Roemerwallklini Gmbh | |
| Mainz, Germany, 55131 | |
| HNO-Gemeinschaftspraxis im Zentrum | |
| Mannheim, Germany, 68161 | |
| Dr .med. Tatjana von Stackelberg | |
| Meerbusch, Germany, 40667 | |
| Dr. med. Ullmann | |
| Melsungen, Germany, 34212 | |
| Dr. med. Wurzer | |
| Muenchen, Germany, 80333 | |
| Dres. med. Bergmann und Davies | |
| Nuertingen, Germany, 72622 | |
| Dr. med Uwe Brinkmann | |
| Oelde, Germany, 59302 | |
| Dr. med. Huegelschaeffer | |
| Philippsburg, Germany, 76661 | |
| Dr. med. Axel Roesler | |
| Radevormwald, Germany, 42477 | |
| Dres. med. Ramming und Waller | |
| Schweinfurt, Germany, 97421 | |
Sponsors and Collaborators
ANM Adaptive Neuromodulation GmbH
Ceres GmbH evaluation & research
More Information
No publications provided
| Responsible Party: | ANM Adaptive Neuromodulation GmbH |
| ClinicalTrials.gov Identifier: | NCT01435317 History of Changes |
| Other Study ID Numbers: | NCT2011-08-26 |
| Study First Received: | August 31, 2011 |
| Last Updated: | April 4, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by ANM Adaptive Neuromodulation GmbH:
|
Acoustic CR®-neuromodulation ANM T30 CR®-System |
Additional relevant MeSH terms:
|
Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013