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

Trials

Study Protocol

Michael Koller¹  Alexandra Stege²  Michael Hummel²  Rilana Cima³  Leyre Hidalgo-Lopez⁴  Sam Denys⁵  Nicolas Verhaert⁵  Nikolaos Markatos⁶  Dimitris Kikidis⁶  Alberto Bernal-Robledano⁷  Marta Martinez-Martinez⁸  Maria Martinez-Martinez⁹  Maria Mata Ferron⁹  Juan Manuel Espinosa-Sanchez⁹  Patricia Perez-Carpena⁹  Jose A. Lopez-Escamez^1,10  Juan Martin-Lagos^1,11  Nicolas Mueller-Locatelli^1,11  Steven C. Marcrum^1,12  Christopher R. Cederroth^1,13  Jorge Simoes^1,14  Stefan Schoisswohl^1,14  Berthold Langguth^1,14  Winfried Schlee^1,14  Axel Schiller^1,14  Susanne Staudinger^1,14  Martin Schecklmann^1,14  Patrick Neff^1,15  Matthias Rose^1,16  Efi Giannopoulou^1,17  Dimitra Chalanouli^1,17  Alvaro Gallego-Martinez^1,18  Paula Robles-Bolivar^1,18  Alba Escalera-Balsera^1,18  Kevin Oppel^1,19  Juliane Dettling-Papargyris^1,19  Tabea Schiele^2,20  Sabine Stark^2,20  Benjamin Boecking^2,20  Birgit Mazurek^2,20 

[1] Center for Clinical Studies, University Hospital Regensburg, Regensburg, Germany;Central Biobank Charité, Charité- Universitätsmedizin Berlin, corporate member of Freie Universität Berlin und Humboldt Universität Berlin, Berlin, Germany;Department of Health Psychology, Katholieke Universiteit Leuven, Leuven, Belgium;Department of Mental Health, Hospital Universitario Virgen de las Nieves, Granada, Spain;Department of Neurosciences, Research group Experimental Oto-Rhino-Laryngology, University of Leuven, Leuven, Belgium;Department of Otorhinolaryngology - Head and Neck surgery, University Hospitals Leuven, Leuven, Belgium;Multidisciplinary University Center for Speech-Language Pathology and Audiology, University Hospitals Leuven, Leuven, Belgium;Department of Otolaryngology, Head and Neck Surgery, National and Kapodistrian University of Athens, Hippocrateion General Hospital, Athens, Greece;Department of Otolaryngology, Instituto de Investigacion Biosanitaria Ibs.GRANADA, Hospital Universitario Virgen de las Nieves, Granada, Spain;Department of Otolaryngology, Instituto de Investigacion Biosanitaria Ibs.GRANADA, Hospital Universitario Virgen de las Nieves, Granada, Spain;Department of Otolaryngology, Instituto de Investigacion Biosanitaria ibs. GRANADA, Hospital Universitario Clinico San Cecilio, Granada, Spain;Department of Otolaryngology, Instituto de Investigacion Biosanitaria Ibs.GRANADA, Hospital Universitario Virgen de las Nieves, Granada, Spain;Otology & 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;Department of Otolaryngology, Instituto de Investigacion Biosanitaria Ibs.GRANADA, Hospital Universitario Virgen de las Nieves, Granada, Spain;Otology & 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;Department of Surgery, Division of Otolaryngology, Universidad de Granada, Granada, Spain;Department of Otolaryngology, Instituto de Investigacion Biosanitaria ibs. GRANADA, Hospital Universitario Clinico San Cecilio, Granada, Spain;Department of Otolaryngology, University Hospital Regensburg, Regensburg, Germany;Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden;Department of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstraße 84, 93053, Regensburg, Germany;Department of Psychiatry and Psychotherapy, University of Regensburg, Universitaetsstraße 84, 93053, Regensburg, Germany;Center for Cognitive Neuroscience and Department of Psychology, University of Salzburg, Salzburg, Austria;Department of Psychosomatic and Psychotherapy, Charité- Universitätsmedizin Berlin, corporate member of Freie Universität Berlin und Humboldt Universität Berlin, Berlin, Germany;EXCELYA Hungary Kft., Budakalász, Hungary;Otology & 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;Terzo-Institute for Applied Hearing Research, ISMA, Sonneberg, Germany;Tinnitus Center, Charité- Universitätsmedizin Berlin, corporate member of Freie Universität Berlin und Humboldt Universität Berlin, Berlin, Germany;

关键词: Tinnitus;    Treatment;    Hearing aids;    Cognitive behavioral therapy;    Sound therapy;    Structured counseling;    Multi-center;    RCT;   

DOI  :  10.1186/s13063-021-05835-z

 received in 2021-05-28, accepted in 2021-11-15,  发布年份 2021

来源: Springer

【 摘 要 】

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.DiscussionResults 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.

【 授权许可】

CC BY   
© The Author(s) 2021. corrected publication 2022

【 图 表 】

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