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

Study Overview
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Brief Summary
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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)

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

Conditions
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Tinnitus

Intervention / Treatment
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* Behavioral: Neuro-Music-Therapy according to the Heidelberg Model
* Behavioral: Counselling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music Therapy<br>Neuro-Music-Therapy according to the Heidelberg Model | Behavioral: Neuro-Music-Therapy according to the Heidelberg Model<br>* 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<br>|
| Active Comparator: Counselling<br>Counselling | Behavioral: Counselling<br>* Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group.<br>|

What is the study measuring?
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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 | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Tinnitus Frequency (Pitch), Obtained at Admission (Pre) and After Therapy Intervention (Post) |  | the average time period was 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subjective evaluation, Tinnitus, music therapy, directive counselling, acoustic stimulation, group comparison, pitch