Clinical trial NCT01845155: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: Tinnitus
music therapy
directive counselling
acoustic stimulation
group comparison
subjective evaluation
pitch
Lead sponsor: German Center for Music Therapy Research
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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")


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

Primary outcomes:
measure: Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) Total Score Change From Baseline to End of Treatment
timeFrame: average time period was 3 months
Secondary outcomes:
measure: Change in Tinnitus Frequency (Pitch), Obtained at Admission (Pre) and After Therapy Intervention (Post)
timeFrame: the average time period was 3 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: German Center for Music Therapy Research
state: Baden-Württemberg
Study officials:
affiliation: German Center for Music Therapy Research
name: Heike Argstatter, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.