Clinical trial NCT01435317: Acoustic Coordinated Reset (CR®) Neuromodulation for the Treatment of Chronic Tonal Tinnitus ("RESET Real Life")
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tinnitus
Keywords: Acoustic CR®-neuromodulation
ANM T30 CR®-System
Lead sponsor: ANM Adaptive Neuromodulation GmbH
Sponsor class: INDUSTRY
Collaborators: name: CERES GmbH
First posted: 2011-09-16
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Improvement of TBF-12 Score or CGI Score
timeFrame: 12 months
Secondary outcomes:
measure: NRS loudness and annoyance (0-100)
timeFrame: 0.5, 1, 2, 3, 6, 9, 12 months
measure: Tinnitus-freedom
timeFrame: 3,6,9,12 months
measure: Compliance
timeFrame: 0.5,1,3,6,9,12 months
measure: Alteration of tinnitus
timeFrame: 0.5,1,2,3,6,9,12 months
measure: Audiogram for hearing loss change
timeFrame: 3,12 months
measure: TBF-12
timeFrame: 3,6,9,12 months
Other outcomes:
Locations:
city: Augsburg
country: Germany
facility: Dr. med. Mueller
city: Bad Bramstedt
country: Germany
facility: Dr. med. Jan Loehler
city: Berlin
country: Germany
facility: Praxisverbund Berlin
city: Berlin
country: Germany
facility: Dr. med. Daniel Osterland
city: Braunschweig
country: Germany
facility: Dres. med. Bodlien/Lingner/Kassuhn
city: Frankfurt
country: Germany
facility: Dres. Lindenberger Wilhelm Ecke Elies Sperl Brackmann
city: Freiburg
country: Germany
facility: Dr. med. Fleissner
city: Fuerth
country: Germany
facility: EuromedClinic
city: Grevenbroich
country: Germany
facility: Dr. med. Hegemann-Gaertner
city: Halle/Saale
country: Germany
facility: Dipl.-Med. Kathrin Stoelzer
city: Koblenz
country: Germany
facility: Dr. med. Hahbrock
city: Koeln
country: Germany
facility: Praxis HNO Koeln Nord
city: Krefeld
country: Germany
facility: Dr. med. Wichmann
city: Mainz
country: Germany
facility: Roemerwallklini Gmbh
city: Mannheim
country: Germany
facility: HNO-Gemeinschaftspraxis im Zentrum
city: Meerbusch
country: Germany
facility: Dr .med. Tatjana von Stackelberg
city: Melsungen
country: Germany
facility: Dr. med. Ullmann
city: Muenchen
country: Germany
facility: Dr. med. Wurzer
city: Nuertingen
country: Germany
facility: Dres. med. Bergmann und Davies
city: Oelde
country: Germany
facility: Dr. med Uwe Brinkmann
city: Philippsburg
country: Germany
facility: Dr. med. Huegelschaeffer
city: Radevormwald
country: Germany
facility: Dr. med. Axel Roesler
city: Schweinfurt
country: Germany
facility: Dres. med. Ramming und Waller
Study officials:
affiliation: HNO-Gemeinschaftspraxis Hamm-Ahlen-Oelde
name: Uwe Brinkmann, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: