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

Tinnitus Clinical Trial

— RRL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01435317
• Other study ID #: NCT2011-08-26
• Status: Completed
• Phase: Phase 4
• First received: August 31, 2011
• Last updated: July 10, 2014
• Start date: November 2011
• Est. completion date: July 2014

Study information

• Verified date: July 2014
• Source: ANM Adaptive Neuromodulation GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Device:
• ANM T30 CR®-System
Stimulation for 4-6h/day for a time of 1 year

Locations

Country	Name	City	State
Germany	Dr. med. Mueller	Augsburg
Germany	Dr. med. Jan Loehler	Bad Bramstedt
Germany	Dr. med. Daniel Osterland	Berlin
Germany	Praxisverbund Berlin	Berlin
Germany	Dres. med. Bodlien/Lingner/Kassuhn	Braunschweig
Germany	Dres. Lindenberger Wilhelm Ecke Elies Sperl Brackmann	Frankfurt
Germany	Dr. med. Fleissner	Freiburg
Germany	EuromedClinic	Fuerth
Germany	Dr. med. Hegemann-Gaertner	Grevenbroich
Germany	Dipl.-Med. Kathrin Stoelzer	Halle/Saale
Germany	Dr. med. Hahbrock	Koblenz
Germany	Praxis HNO Koeln Nord	Koeln
Germany	Dr. med. Wichmann	Krefeld
Germany	Roemerwallklini Gmbh	Mainz
Germany	HNO-Gemeinschaftspraxis im Zentrum	Mannheim
Germany	Dr .med. Tatjana von Stackelberg	Meerbusch
Germany	Dr. med. Ullmann	Melsungen
Germany	Dr. med. Wurzer	Muenchen
Germany	Dres. med. Bergmann und Davies	Nuertingen
Germany	Dr. med Uwe Brinkmann	Oelde
Germany	Dr. med. Huegelschaeffer	Philippsburg
Germany	Dr. med. Axel Roesler	Radevormwald
Germany	Dres. med. Ramming und Waller	Schweinfurt

Sponsors (2)

Lead Sponsor	Collaborator
ANM Adaptive Neuromodulation GmbH	CERES GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of TBF-12 Score or CGI Score	Change of tinnitus severity, measured by TBF-12 Score or CGI score change from baseline to end of treatment.	12 months	No
Secondary	NRS loudness and annoyance (0-100)		0.5, 1, 2, 3, 6, 9, 12 months	No
Secondary	Tinnitus-freedom		3,6,9,12 months	No
Secondary	Compliance	Questioning if the specified application was kept.	0.5,1,3,6,9,12 months	No
Secondary	Alteration of tinnitus	Early alteration of tinnitus frequency and psychometric tinnitus loudness, measured with the ANM T30 CR®-System.	0.5,1,2,3,6,9,12 months	No
Secondary	Audiogram for hearing loss change		3,12 months	No
Secondary	TBF-12		3,6,9,12 months	No