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

Primary Purpose

Tinnitus

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Neuro-Music-Therapy according to the Heidelberg Model
Counselling
Sponsored by
German Center for Music Therapy Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring Tinnitus, music therapy, directive counselling, acoustic stimulation, group comparison, subjective evaluation, pitch

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • German Center for Music Therapy Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Music Therapy

Counselling

Arm Description

Neuro-Music-Therapy according to the Heidelberg Model

Counselling

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Tinnitus Frequency (Pitch), Obtained at Admission (Pre) and After Therapy Intervention (Post)

Full Information

First Posted
April 24, 2013
Last Updated
February 19, 2014
Sponsor
German Center for Music Therapy Research
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1. Study Identification

Unique Protocol Identification Number
NCT01845155
Brief Title
Neuro-Music-Therapy for Patients With Chronic Tinnitus - a Controlled Clinical Trial
Official Title
Neuro-Music-Therapy for Patients With Chronic Tinnitus - a Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German Center for Music Therapy Research

4. Oversight

5. Study Description

Brief Summary
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")

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
Tinnitus, music therapy, directive counselling, acoustic stimulation, group comparison, subjective evaluation, pitch

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Music Therapy
Arm Type
Experimental
Arm Description
Neuro-Music-Therapy according to the Heidelberg Model
Arm Title
Counselling
Arm Type
Active Comparator
Arm Description
Counselling
Intervention Type
Behavioral
Intervention Name(s)
Neuro-Music-Therapy according to the Heidelberg Model
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Counselling
Intervention Description
Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group.
Primary Outcome Measure Information:
Title
Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) Total Score Change From Baseline to End of Treatment
Description
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.
Time Frame
average time period was 3 months
Secondary Outcome Measure Information:
Title
Change in Tinnitus Frequency (Pitch), Obtained at Admission (Pre) and After Therapy Intervention (Post)
Time Frame
the average time period was 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heike Argstatter, Dr
Organizational Affiliation
German Center for Music Therapy Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
German Center for Music Therapy Research
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69123
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22993646
Citation
Argstatter H, Grapp M, Hutter E, Plinkert P, Bolay HV. Long-term effects of the "Heidelberg Model of Music Therapy" in patients with chronic tinnitus. Int J Clin Exp Med. 2012;5(4):273-88. Epub 2012 Aug 22.
Results Reference
background
PubMed Identifier
25224125
Citation
Argstatter H, Grapp M, Hutter E, Plinkert PK, Bolay HV. The effectiveness of neuro-music therapy according to the Heidelberg model compared to a single session of educational counseling as treatment for tinnitus: a controlled trial. J Psychosom Res. 2015 Mar;78(3):285-92. doi: 10.1016/j.jpsychores.2014.08.012. Epub 2014 Sep 3.
Results Reference
derived

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

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