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

Phase 4

Completed

• Conditions: Tinnitus
• Interventions: Device: ANM T30 CR®-System

• Registration Number: NCT01435317
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-08-31
• Study First Submitted QC: 2011-09-15
• Study First Posted: 2011-09-16
• Study Start: 2011-11
• Primary Completion: 2013-06
• Status Verified: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2014-07-10
• Last Update Posted: 2014-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
standard	ANM T30 CR®-System	Standard treatment with the ANM T30 CR®-System

Primary Outcome Measures

Name	Time	Method
Improvement of TBF-12 Score or CGI Score	12 months	Change of tinnitus severity, measured by TBF-12 Score or CGI score change from baseline to end of treatment.

Secondary Outcome Measures

Name	Time	Method
Tinnitus-freedom	3,6,9,12 months
Compliance	0.5,1,3,6,9,12 months	Questioning if the specified application was kept.
Audiogram for hearing loss change	3,12 months
TBF-12	3,6,9,12 months
Alteration of tinnitus	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.
NRS loudness and annoyance (0-100)	0.5, 1, 2, 3, 6, 9, 12 months

Trial Locations

Locations (23)

Dr. med. Hahbrock; 🇩🇪 Koblenz, Germany

Dr. med. Wichmann; 🇩🇪 Krefeld, Germany

HNO-Gemeinschaftspraxis im Zentrum; 🇩🇪 Mannheim, Germany

Dr .med. Tatjana von Stackelberg; 🇩🇪 Meerbusch, Germany

Dr. med. Huegelschaeffer; 🇩🇪 Philippsburg, Germany

Dipl.-Med. Kathrin Stoelzer; 🇩🇪 Halle/Saale, Germany

Roemerwallklini Gmbh; 🇩🇪 Mainz, Germany

Dr. med. Wurzer; 🇩🇪 Muenchen, Germany

Praxis HNO Koeln Nord; 🇩🇪 Koeln, Germany

Dres. Lindenberger Wilhelm Ecke Elies Sperl Brackmann; 🇩🇪 Frankfurt, Germany

Dr. med. Axel Roesler; 🇩🇪 Radevormwald, Germany

Dr. med. Mueller; 🇩🇪 Augsburg, Germany

Dr. med. Ullmann; 🇩🇪 Melsungen, Germany

Dres. med. Bergmann und Davies; 🇩🇪 Nuertingen, Germany

Dres. med. Ramming und Waller; 🇩🇪 Schweinfurt, Germany

Praxisverbund Berlin; 🇩🇪 Berlin, Germany

Dr. med. Jan Loehler; 🇩🇪 Bad Bramstedt, Germany

Dr. med. Daniel Osterland; 🇩🇪 Berlin, Germany

Dres. med. Bodlien/Lingner/Kassuhn; 🇩🇪 Braunschweig, Germany

Dr. med. Hegemann-Gaertner; 🇩🇪 Grevenbroich, Germany

EuromedClinic; 🇩🇪 Fuerth, Germany

Dr. med. Fleissner; 🇩🇪 Freiburg, Germany

Dr. med Uwe Brinkmann; 🇩🇪 Oelde, Germany