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

NCT ID: NCT01845155

Last Updated: 2014-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2013-02-28

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")

Conditions

Tinnitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Music Therapy

Neuro-Music-Therapy according to the Heidelberg Model

Group Type: EXPERIMENTAL

Neuro-Music-Therapy according to the Heidelberg Model

Intervention Type: BEHAVIORAL

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

Counselling

Counselling

Group Type: ACTIVE_COMPARATOR

Counselling

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Counselling

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Center for Music Therapy Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heike Argstatter, Dr

Role: PRINCIPAL_INVESTIGATOR

German Center for Music Therapy Research

Locations

German Center for Music Therapy Research

Heidelberg, Baden-Wurttemberg, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 22993646 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25224125 (View on PubMed)

Other Identifiers

CMTR-TC-02

Identifier Type: -

Identifier Source: org_study_id