RT Journal Article
T1 Unification of Treatments and Interventions for Tinnitus Patients (UNITI): a study protocol for a multi-center randomized clinical trial.
A1 Schoisswohl, Stefan
A1 Langguth, Berthold
A1 Schecklmann, Martin
A1 Bernal-Robledano, Alberto
A1 Boecking, Benjamin
A1 Cederroth, Christopher R
A1 Chalanouli, Dimitra
A1 Cima, Rilana
A1 Denys, Sam
A1 Dettling-Papargyris, Juliane
A1 Escalera-Balsera, Alba
A1 Espinosa-Sanchez, Juan Manuel
A1 Gallego-Martinez, Alvaro
A1 Giannopoulou, Efi
A1 Hidalgo-Lopez, Leyre
A1 Hummel, Michael
A1 Kikidis, Dimitris
A1 Koller, Michael
A1 Lopez-Escamez, Jose A
A1 Marcrum, Steven C
A1 Markatos, Nikolaos
A1 Martin-Lagos, Juan
A1 Martinez-Martinez, Maria
A1 Martinez-Martinez, Marta
A1 Ferron, Maria Mata
A1 Mazurek, Birgit
A1 Mueller-Locatelli, Nicolas
A1 Neff, Patrick
A1 Oppel, Kevin
A1 Perez-Carpena, Patricia
A1 Robles-Bolivar, Paula
A1 Rose, Matthias
A1 Schiele, Tabea
A1 Schiller, Axel
A1 Simoes, Jorge
A1 Stark, Sabine
A1 Staudinger, Susanne
A1 Stege, Alexandra
A1 Verhaert, Nicolas
A1 Schlee, Winfried
K1 Cognitive behavioral therapy
K1 Hearing aids
K1 Multi-center
K1 RCT
K1 Sound therapy
K1 Structured counseling
K1 Tinnitus
K1 Treatment
AB 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). 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. 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. ClinicalTrials.gov NCT04663828 . Registered on 11 December 2020.
YR 2021
FD 2021-12-04
LK https://hdl.handle.net/10668/26226
UL https://hdl.handle.net/10668/26226
LA en
DS RISalud
RD Apr 5, 2025