NCT01845155

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")

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 3, 2013

Completed
7 months until next milestone

Results Posted

Study results publicly available

November 18, 2013

Completed
Last Updated

March 17, 2014

Status Verified

February 1, 2014

Enrollment Period

6.8 years

First QC Date

April 24, 2013

Results QC Date

September 4, 2013

Last Update Submit

February 19, 2014

Conditions

Tinnitus

Keywords

Tinnitusmusic therapydirective counsellingacoustic stimulationgroup comparisonsubjective evaluationpitch

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

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

    the average time period was 3 months

Study Arms (2)

Music Therapy

EXPERIMENTAL

Neuro-Music-Therapy according to the Heidelberg Model

Behavioral: Neuro-Music-Therapy according to the Heidelberg Model

Counselling

ACTIVE COMPARATOR

Counselling

Behavioral: Counselling

Interventions

Neuro-Music-Therapy according to the Heidelberg ModelBEHAVIORAL

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

Music Therapy
CounsellingBEHAVIORAL

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

Counselling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

German Center for Music Therapy Research

Heidelberg, Baden-Wurttemberg, 69123, Germany

Location

Related Publications (2)

  • 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.

    PMID: 22993646BACKGROUND

  • 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.

    PMID: 25224125DERIVED

MeSH Terms

Conditions

Tinnitus

Interventions

Counseling

Condition Hierarchy (Ancestors)

Hearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Results Point of Contact

Title
Dr. Heike Argstatter
Organization
Deutsches Zentrum für Musiktherapieforschung (Viktor Dulger Institut) DZM e.V. - German Center for Music Therapy Research
heike.argstatter@dzm-heidelberg.de
+49-6221-7963960

Study Officials

  • Heike Argstatter, Dr

    German Center for Music Therapy Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2013

First Posted

May 3, 2013

Study Start

March 1, 2006

Primary Completion

January 1, 2013

Study Completion

February 1, 2013

Last Updated

March 17, 2014

Results First Posted

November 18, 2013

Record last verified: 2014-02

Locations

DE(1)