Evidence map›Paper›PMID 34863270›Full record

ArticleTrials2021

Unification of Treatments and Interventions for Tinnitus Patients (UNITI): a study protocol for a multi-center randomized clinical trial.

Stefan Schoisswohl, Berthold Langguth, Martin Schecklmann, Alberto Bernal-Robledano, Benjamin Boecking, Christopher R Cederroth, Dimitra Chalanouli, Rilana Cima, Sam Denys, Juliane Dettling-Papargyris and 30 more

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04663828 (UNification of Treatments and Interventions for TInnitus Patients - Randomized Clinical Trial), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
2.0field-weighted citation impact, top 14% of its field
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.

NCT04663828 nacompletednot on this map

UNification of Treatments and Interventions for TInnitus Patients - Randomized Clinical Trial (UNITI-RCT)

TypeinterventionalSponsorUNITI ConsortiumRan2021 to 2023Enrolled500ConditionsTinnitusArmsStructured counseling, Hearing aids, Cognitive behavioral therapy, Sound therapy
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 26 citations in OpenAlex.

  1. Trial
  2. Estimation of Minimal Clinically Important Difference for Tinnitus Handicap Inventory and Tinnitus Functional Index.Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery · 2025
    Trial
  3. Trial
  4. Article
  5. Review
  6. Brief Acoustic Tinnitus Suppression as a Diagnostic Procedure in Clinical Routine: Feasibility and Results.Journal of the Association for Research in Otolaryngology : JARO · 2025
    Article
  7. Article
  8. Article
  9. Article
  10. The Current State of Tinnitus Diagnosis and Treatment: a Multidisciplinary Expert Perspective.Journal of the Association for Research in Otolaryngology : JARO · 2024
    Review
  11. Cognitive Screening and Hearing Assessment in Patients With Chronic Tinnitus.Clinical and experimental otorhinolaryngology · 2024
    Article
  12. Article
  13. Tinnitus Guidelines and Their Evidence Base.Journal of clinical medicine · 2023
    Article
  14. Article
  15. Article
  16. 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

40 authors at 11 institutions in 6 countries.

Stefan SchoisswohlDepartment of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstraße 84, 93053, Regensburg, Germany. stefanschoisswohl@yahoo.de.ORCID http://orcid.org/0000-0003-3633-999X
Berthold LangguthDepartment of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstraße 84, 93053, Regensburg, Germany.
Martin SchecklmannDepartment of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstraße 84, 93053, Regensburg, Germany.
Alberto Bernal-RobledanoDepartment of Otolaryngology, Instituto de Investigacion Biosanitaria Ibs.GRANADA, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Benjamin BoeckingTinnitus Center, Charité- Universitätsmedizin Berlin, corporate member of Freie Universität Berlin und Humboldt Universität Berlin, Berlin, Germany.
Christopher R CederrothDepartment of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.
Dimitra ChalanouliEXCELYA Hungary Kft., Budakalász, Hungary.
Rilana CimaDepartment of Health Psychology, Katholieke Universiteit Leuven, Leuven, Belgium.
Sam DenysDepartment of Neurosciences, Research group Experimental Oto-Rhino-Laryngology, University of Leuven, Leuven, Belgium.
Juliane Dettling-PapargyrisTerzo-Institute for Applied Hearing Research, ISMA, Sonneberg, Germany.
Alba Escalera-BalseraOtology & Neurotology Group CTS 495, Department of Genomic Medicine, GENYO, Center for Genomics and Oncological Research: Pfizer/University of Granada/Andalusian Regional Government, PTS Granada, Granada, Spain.
Juan Manuel Espinosa-SanchezDepartment of Otolaryngology, Instituto de Investigacion Biosanitaria Ibs.GRANADA, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Alvaro Gallego-MartinezOtology & Neurotology Group CTS 495, Department of Genomic Medicine, GENYO, Center for Genomics and Oncological Research: Pfizer/University of Granada/Andalusian Regional Government, PTS Granada, Granada, Spain.
Efi GiannopoulouEXCELYA Hungary Kft., Budakalász, Hungary.
Leyre Hidalgo-LopezDepartment of Mental Health, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Michael HummelCentral Biobank Charité, Charité- Universitätsmedizin Berlin, corporate member of Freie Universität Berlin und Humboldt Universität Berlin, Berlin, Germany.
Dimitris KikidisDepartment of Otolaryngology, Head and Neck Surgery, National and Kapodistrian University of Athens, Hippocrateion General Hospital, Athens, Greece.
Michael KollerCenter for Clinical Studies, University Hospital Regensburg, Regensburg, Germany.
Jose A Lopez-EscamezDepartment of Otolaryngology, Instituto de Investigacion Biosanitaria Ibs.GRANADA, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Steven C MarcrumDepartment of Otolaryngology, University Hospital Regensburg, Regensburg, Germany.
Nikolaos MarkatosDepartment of Otolaryngology, Head and Neck Surgery, National and Kapodistrian University of Athens, Hippocrateion General Hospital, Athens, Greece.
Juan Martin-LagosDepartment of Otolaryngology, Instituto de Investigacion Biosanitaria ibs. GRANADA, Hospital Universitario Clinico San Cecilio, Granada, Spain.
Maria Martinez-MartinezDepartment of Otolaryngology, Instituto de Investigacion Biosanitaria Ibs.GRANADA, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Marta Martinez-MartinezDepartment of Otolaryngology, Instituto de Investigacion Biosanitaria Ibs.GRANADA, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Maria Mata FerronDepartment of Otolaryngology, Instituto de Investigacion Biosanitaria Ibs.GRANADA, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Birgit MazurekTinnitus Center, Charité- Universitätsmedizin Berlin, corporate member of Freie Universität Berlin und Humboldt Universität Berlin, Berlin, Germany.
Nicolas Mueller-LocatelliDepartment of Otolaryngology, Instituto de Investigacion Biosanitaria ibs. GRANADA, Hospital Universitario Clinico San Cecilio, Granada, Spain.
Patrick NeffDepartment of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstraße 84, 93053, Regensburg, Germany.
Kevin OppelTerzo-Institute for Applied Hearing Research, ISMA, Sonneberg, Germany.
Patricia Perez-CarpenaDepartment of Otolaryngology, Instituto de Investigacion Biosanitaria Ibs.GRANADA, Hospital Universitario Virgen de las Nieves, Granada, Spain.
Paula Robles-BolivarOtology & Neurotology Group CTS 495, Department of Genomic Medicine, GENYO, Center for Genomics and Oncological Research: Pfizer/University of Granada/Andalusian Regional Government, PTS Granada, Granada, Spain.
Matthias RoseDepartment of Psychosomatic and Psychotherapy, Charité- Universitätsmedizin Berlin, corporate member of Freie Universität Berlin und Humboldt Universität Berlin, Berlin, Germany.
Tabea SchieleTinnitus Center, Charité- Universitätsmedizin Berlin, corporate member of Freie Universität Berlin und Humboldt Universität Berlin, Berlin, Germany.
Axel SchillerDepartment of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstraße 84, 93053, Regensburg, Germany.
Jorge SimoesDepartment of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstraße 84, 93053, Regensburg, Germany.
Sabine StarkTinnitus Center, Charité- Universitätsmedizin Berlin, corporate member of Freie Universität Berlin und Humboldt Universität Berlin, Berlin, Germany.
Susanne StaudingerDepartment of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstraße 84, 93053, Regensburg, Germany.
Alexandra StegeCentral Biobank Charité, Charité- Universitätsmedizin Berlin, corporate member of Freie Universität Berlin und Humboldt Universität Berlin, Berlin, Germany.
Nicolas VerhaertDepartment of Neurosciences, Research group Experimental Oto-Rhino-Laryngology, University of Leuven, Leuven, Belgium.
Winfried SchleeDepartment of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstraße 84, 93053, Regensburg, Germany.
Instituto de Investigación Biosanitaria de Granada · ESHumboldt-Universität zu Berlin · DEUniversity of Regensburg · DEKU Leuven · BEPfizer-University of Granada-Junta de Andalucía Centre for Genomics and Oncological Research · ESNational and Kapodistrian University of Athens · GRUniversity Hospital Regensburg · DEHospital Universitario Virgen de las Nieves · ESKarolinska Institutet · SEUniversidad de Granada · ESUniversity of Salzburg · AT

Funding

Horizon 2020 848261).
6 · The paper itself

Abstract

backgroundTinnitus represents a relatively common condition in the global population accompanied by various comorbidities and severe burden in many cases. Nevertheless, there is currently no general treatment or cure, presumable due to the heterogeneity of tinnitus with its wide variety of etiologies and tinnitus phenotypes. Hence, most treatment studies merely demonstrated improvement in a subgroup of tinnitus patients. The majority of studies are characterized by small sample sizes, unstandardized treatments and assessments, or applications of interventions targeting only a single organ level. Combinatory treatment approaches, potentially targeting multiple systems as well as treatment personalization, might provide remedy and enhance treatment responses. The aim of the present study is to systematically examine established tinnitus therapies both alone and in combination in a large sample of tinnitus patients. Further, it wants to provide the basis for personalized treatment approaches by evaluating a specific decision support system developed as part of an EU-funded collaborative project (Unification of treatments and interventions for tinnitus patients; UNITI project). METHODS/STUDY

designThis is a multi-center parallel-arm randomized clinical trial conducted at five different clinical sites over the EU. The effect of four different tinnitus therapy approaches (sound therapy, structured counseling, hearing aids, cognitive behavioral therapy) applied over a time period of 12 weeks as a single or rather a combinatory treatment in a total number of 500 chronic tinnitus patients will be investigated. Assessments and interventions are harmonized over the involved clinical sites. The primary outcome measure focuses on the domain tinnitus distress assessed via the Tinnitus Handicap Inventory. DISCUSSION: Results and conclusions from the current study might not only provide an essential contribution to combinatory and personalized treatment approaches in tinnitus but could also provide more profound insights in the heterogeneity of tinnitus, representing an important step towards a cure for tinnitus.

trial registrationClinicalTrials.gov NCT04663828 . Registered on 11 December 2020.

Indexed as

Cognitive Behavioral TherapyHearing AidsTinnitusCounselingHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicCognitive behavioral therapyHearing aidsMulti-centerRCTSound therapyStructured counselingTinnitusTreatment

Identifiers

PMID34863270
PMCPMC8642746
OpenAlexW4226072015

What Socratic holds

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LicenceCC BY
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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 Socratic graph.