N/A
N=290
Neuro-Music-Therapy for Patients With Chronic Tinnitus - a Controlled Clinical Trial
Tinnitus
Bottom Line
View on ClinicalTrials.gov: NCT01845155 ↗Enrolled (actual)
290
Serious AEs
—
Results posted
Nov 2013
Primary outcome: Primary: Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) Total Score Change From Baseline to End of Treatment — 13.6; 3.7 absolute TF-score change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Neuro-Music-Therapy according to the Heidelberg Model (Behavioral); Counselling (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- German Center for Music Therapy Research
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tinnitus Questionnaire (TQ, Goebel and Hiller 1998) Total Score Change From Baseline to End of Treatment |
13.6; 3.7 | — |
| SECONDARY Change in Tinnitus Frequency (Pitch), Obtained at Admission (Pre) and After Therapy Intervention (Post) |
2342; 530 | — |
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
Data sourced from ClinicalTrials.gov (NCT01845155). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.