Evidence map›Paper›PMID 26987755›Full record

Trial reportBMC neurology2016

Clinical trial on tonal tinnitus with tailor-made notched music training.

Alwina Stein, Robert Wunderlich, Pia Lau, Alva Engell, Andreas Wollbrink, Alex Shaykevich, Jörg-Tobias Kuhn, Heinz Holling, Claudia Rudack, Christo Pantev

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC neurology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05417711 (Efficacy of Transcutaneous Vagus Nerve Stimulation Paired With Tailor-Made Notched Music Therapy Versus Tailor-made Notched Music Training for Chronic Subjective Tinnitus), which is not on this map. Cited by 46 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05417711 nanot yet recruitingnot on this mapstarted 2023, after this paper: background citation

Efficacy of Transcutaneous Vagus Nerve Stimulation Paired With Tailor-Made Notched Music Therapy Versus Tailor-made Notched Music Training for Chronic Subjective Tinnitus: A Multicenter, Randomized, Double-blind, Controlled Clinical Trial

TypeinterventionalSponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityRan2023 to 2026Enrolled388ConditionsTinnitus, Subjective, Vagus Nerve Stimulation, Music Therapy, Double-Blind MethodArmsTranscutaneous Vagus Nerve Stimulation Paired with Tailor-Made Notched Music Therapy, Tailor-made Notched Music Training
3 · Its place in the literature

Who cites it

46 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Efficacy of tailor-made notched music training (TMNMT) in the treatment of tinnitus: a systematic review and meta-analysis.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2024
    Pooled it
  2. Guideline
  3. Guideline
  4. A Randomized, Controlled Trial of Notched Music Therapy for Tinnitus Patients.The journal of international advanced otology · 2021
    Trial
  5. Article
  6. Review
  7. Music Therapy and Tinnitus Treatment: Systematic Review and Meta-Analysis.International archives of otorhinolaryngology · 2026
    Review
  8. Article
  9. Article
  10. Review
  11. Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Chronic Tinnitus.Deutsches Arzteblatt international · 2022
    Review
  19. HNO-Nachrichten · 2022
    Review
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Alwina SteinInstitute for Biomagnetism and Biosignalanalysis, University of Münster, Malmedyweg 15, 48149, Münster, Germany.
Robert WunderlichInstitute for Biomagnetism and Biosignalanalysis, University of Münster, Malmedyweg 15, 48149, Münster, Germany.
Pia LauInstitute for Biomagnetism and Biosignalanalysis, University of Münster, Malmedyweg 15, 48149, Münster, Germany.
Alva EngellInstitute for Biomagnetism and Biosignalanalysis, University of Münster, Malmedyweg 15, 48149, Münster, Germany.
Andreas WollbrinkInstitute for Biomagnetism and Biosignalanalysis, University of Münster, Malmedyweg 15, 48149, Münster, Germany.
Alex Shaykevich, 2/22 Foyle Road, Bayswater, WA, 6053, Australia.
Jörg-Tobias KuhnInstitute for Psychology, University of Münster, Fliednerstraße 21, 48149, Münster, Germany.
Heinz HollingInstitute for Psychology, University of Münster, Fliednerstraße 21, 48149, Münster, Germany.
Claudia RudackDepartment of ENT, University Clinic Münster, University of Münster, Cardinal-von-Galen Ring 10, 48149, Münster, Germany.
Christo PantevInstitute for Biomagnetism and Biosignalanalysis, University of Münster, Malmedyweg 15, 48149, Münster, Germany. pantev@uni-muenster.de.ORCID http://orcid.org/0000-0003-3347-8812

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTinnitus is a result of hyper-activity/hyper-synchrony of auditory neurons coding the tinnitus frequency, which has developed due to synchronous mass activity owing to the lack of inhibition. We assume that removal of exactly these frequencies from a complex auditory stimulus will cause the brain to reorganize around tonotopic regions coding the tinnitus frequency through inhibition-induced plasticity. Based on this assumption, a novel treatment for tonal tinnitus--tailor-made notched music training (TMNMT)--has been introduced and was tested in this clinical trial.

methodsA randomized controlled trial in parallel group design was performed in a double-blinded manner. We included 100 participants with chronic, tonal tinnitus who listened to tailor-made notched music for two hours a day for three consecutive months. Our primary outcome measures were the Tinnitus Handicap Questionnaire and Visual Analog Scales measuring perceived tinnitus loudness, awareness, distress and handicap. Participants rated their tinnitus before and after the training as well as one month after cessation of the training.

resultsWhile no effect was found for the primary outcome measures, tinnitus distress, as measured by the Tinnitus Questionnaire, a secondary outcome measure, developed differently in the two groups. The treatment group showed higher distress scores while the placebo group revealed lower distress scores after the training. However, this effect did not reach significance in post-hoc analysis and disappeared at follow-up measurements. At follow-up, tinnitus loudness in the treatment group was significantly reduced as compared to the control group. Post hoc analysis, accounting for low reliability scores in the Visual Analog Scales, showed a significant reduction of the overall Visual Analog Scale mean score in the treatment group even at the post measurement.

conclusionThis is the first study on TMNMT that was planned and conducted following the CONSORT statement standards for clinical trials. The current work is one more step towards a final evaluation of TMNMT. Already after three months the effect of training with tailor-made notched music is observable in the most direct rating of tinnitus perception - the tinnitus loudness, while more global measures of tinnitus distress do not show relevant changes.

trial registrationCurrent Controlled Trials ISRCTN04840953; Trial registration date: 17.07.2013.

Indexed as

MusicAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedMusic TherapyReproducibility of ResultsSurveys and QuestionnairesTinnitusTreatment OutcomeYoung AdultClinical trialLateral inhibitionTailor-made notched music training (TMNMT)Tonal tinnitus

Identifiers

PMID26987755
PMCPMC4797223

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.