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:

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

History of Changes

Tracking Information
First Received Date ^ICMJE	August 31, 2011
Last Updated Date	April 4, 2012
Start Date ^ICMJE	November 2011
Estimated Primary Completion Date	May 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 15, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01435317 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 26, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: September 15, 2011)	VAS loudness and annoyance (0-100) - 1° at each visit [ 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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Acoustic Coordinated Reset (CR®) Neuromodulation for the Treatment of Chronic Tonal Tinnitus ("RESET Real Life")
Official Title ^ICMJE	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
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Tinnitus
Intervention ^ICMJE	Device: ANM T30 CR®-System Stimulation for 4-6h/day for a time of 1 year Other Name: ANM T30 CR®-System
Study Arm (s)	Experimental: standard Standard treatment with the ANM T30 CR®-System Intervention: Device: ANM T30 CR®-System
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	200
Estimated Completion Date	July 2013
Estimated Primary Completion Date	May 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01435317
Other Study ID Numbers ^ICMJE	NCT2011-08-26
Has Data Monitoring Committee	Yes
Responsible Party	ANM Adaptive Neuromodulation GmbH
Study Sponsor ^ICMJE	ANM Adaptive Neuromodulation GmbH
Collaborators ^ICMJE	Ceres GmbH evaluation & research
Investigators ^ICMJE	Not Provided
Information Provided By	ANM Adaptive Neuromodulation GmbH
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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