Unification of Treatments and Interventions for Tinnitus Patients (UNITI): a study protocol for a multi-center randomized clinical trial
Creators: name: Schoisswohl, Stefan
name: Langguth, Berthold
name: Schecklmann, Martin
name: Bernal-Robledano, Alberto
name: Boecking, Benjamin
name: Cederroth, Christopher R.
name: Chalanouli, Dimitra
name: Cima, Rilana
name: Denys, Sam
name: Dettling-Papargyris, Juliane
name: Escalera-Balsera, Alba
name: Espinosa-Sanchez, Juan Manuel
name: Gallego-Martinez, Alvaro
name: Giannopoulou, Efi
name: Hidalgo-Lopez, Leyre
name: Hummel, Michael
name: Kikidis, Dimitris
name: Koller, Michael
name: Lopez-Escamez, Jose A.
name: Marcrum, Steven C.
name: Markatos, Nikolaos
name: Martin-Lagos, Juan
name: Martinez-Martinez, Maria
name: Martinez-Martinez, Marta
name: Ferron, Maria Mata
name: Mazurek, Birgit
name: Mueller-Locatelli, Nicolas
name: Neff, Patrick
name: Oppel, Kevin
name: Perez-Carpena, Patricia
name: Robles-Bolivar, Paula
name: Rose, Matthias
name: Schiele, Tabea
name: Schiller, Axel
name: Simoes, Jorge
name: Stark, Sabine
name: Staudinger, Susanne
name: Stege, Alexandra
name: Verhaert, Nicolas
name: Schlee, Winfried
Publisher: name: Universität Regensburg
Year: 2021
Subjects: subject: QUALITY-OF-LIFE; HEARING-LOSS; SEVERITY; THERAPY; COMBINATION; MANAGEMENT; DISORDERS; ANXIETY; SOUND; PHQ-9; Tinnitus; Treatment; Hearing aids; Cognitive behavioral therapy; Sound therapy; Structured counseling; Multi-center; RCT
subject: 610 Medizin

description: Background: Tinnitus 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 design: This 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.