Neuro-Music-Therapy for Patients With Chronic Tinnitus - a Controlled Clinical Trial

February 19, 2014 updated by: German Center for Music Therapy Research

BACKGROUND: Tinnitus is a nonspecific symptom of hearing disorder characterized by the sensation of buzzing, ringing, clicking, pulsations, and other noises in the ear. Despite a variety of treatments, many patients with chronic tinnitus ask for more active ways in coping with their tinnitus. Gold standard treatment in chronic tinnitus is a comprehensive directive counseling explaining the underlying mechanisms leading to the tinnitus percept. Therefore a neuro-music therapeutic treatment based on a bio-psycho-social framework was developed and compared to a counselling-only control group.

INTERVENTION: two standardized protocols for tinnitus therapy were defined ("neuro-music therapy" vs. "counselling")

Study Overview

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69123
        • German Center for Music Therapy Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of chronic tinnitus persisting for a minimum of 6 month
  • Adults, aged 18 or over
  • Patients are able to understand, read and speak German fluently
  • Patients are able to give written informed consent
  • tinnitus with determinable centre frequency

Exclusion Criteria:

  • Tinnitus related to anatomic lesions of the ear, to retrocochlear lesions or to cochlear implantation
  • Tinnitus is concomitant symptom of a known systemic disease (such as Menière's Disease, vestibular schwannoma, endolymphatic hydrops)
  • Status following craniocerebral trauma, cervicogenic or stomatognathic tinnitus
  • Tinnitus is neither noisiform nor tonal (cricking, clacking, rumbling) or has different sound components or is pulsatile, intermittent or non-persistent
  • Severe hearing impairment (greater than 50 decibel hearing loss (dB HL) in the region of the centre tinnitus frequency)
  • Severe hyperacusis
  • One or two sided deafness
  • Clinical diagnosis of severe mental disorder or psychiatric or neurological disease (psychosis, epilepsy, Parkinsons's disease, dementia, alcohol or drug abuse)
  • History of severe ischemic disorder (previous stoke, previous heart attack, peripheral arterial occlusion disease)
  • Inability to discontinue drugs known to be associated with tinnitus (high-dose aspirin, quinidine, aminoglycosides) or psychotropic medication prior to entry into the study
  • Patients are not able to understand, read and speak German fluently
  • Patients are not able to give written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Music Therapy
Neuro-Music-Therapy according to the Heidelberg Model

The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.

For more details on the music therapy see Argstatter et al. 2012

Active Comparator: Counselling
Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) Total Score Change From Baseline to End of Treatment
Time Frame: average time period was 3 months
Tinnitus severity was assessed by the German version of the tinnitus questionnaire (TQ, Goebel and Hiller 1994). The TQ consists of a total of 52 items. The questionnaire records tinnitus related complaints on a global TQ-score. The range of values is between the minimum score of 0 and the maximum score of 84, whereas high values indicate high tinnitus related distress.
average time period was 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Tinnitus Frequency (Pitch), Obtained at Admission (Pre) and After Therapy Intervention (Post)
Time Frame: the average time period was 3 months
the average time period was 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Heike Argstatter, Dr, German Center for Music Therapy Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

April 24, 2013

First Submitted That Met QC Criteria

April 29, 2013

First Posted (Estimate)

May 3, 2013

Study Record Updates

Last Update Posted (Estimate)

March 17, 2014

Last Update Submitted That Met QC Criteria

February 19, 2014

Last Verified

February 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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