| Creators: |
Simoes, Jorge P. and Schoisswohl, Stefan and Schlee, Winfried and Basso, Laura and Bernal-Robledano, Alberto and Boecking, Benjamin and Cima, Rilana and Engelke, Milena and Escaler-Balsera, Alba and Gallego-Martinez, Alvaro and Gallus, Silvano and Kikidis, Dimitris and López-Escámez, Jose and Marcrum, Steven C. and Markatos, Nicolaos and Martin-Lagos, Juan and Martinez-Martinez, Marta and Mazurek, Birgit and Vassou, Evgenia and Jarach, Carlotta M. and Mueller-Locatelli, Nicolas and Neff, Patrick and Niemann, Uli and Hafez, Kader O. and Puga, Clara and Schleicher, Miro and Unnikrishnan, Vishnu and Perez-Carpena, Patricia and Pryss, Rüdiger and Robles-Bolivar, Paula and Rose, Matthias and Schecklmann, Martin and Schiele, Tabea and Schobel, Johannes and Spiliopoulou, Myra and Stark, Sabine and Vogel, Carsten and Wunder, Nina |
| Abstract (ENG): |
Background
Tinnitus is a leading cause of disease burden globally. Several therapeutic strategies are recommended in guidelines for the reduction of tinnitus distress; however, little is known about the potentially increased effectiveness of a combination of treatments and personalized treatments for each tinnitus patient.
Methods
Within the Unification of Treatments and Interventions for Tinnitus Patients project, a multicenter, randomized clinical trial is conducted with the aim to compare the effectiveness of single treatments and combined treatments on tinnitus distress (UNITI-RCT). Five different tinnitus centers across Europe aim to treat chronic tinnitus patients with either cognitive behavioral therapy, sound therapy, structured counseling, or hearing aids alone, or with a combination of two of these treatments, resulting in four treatment arms with single treatment and six treatment arms with combinational treatment. This statistical analysis plan describes the statistical methods to be deployed in the UNITI-RCT.
Discussion
The UNITI-RCT trial will provide important evidence about whether a combination of treatments is superior to a single treatment alone in the management of chronic tinnitus patients. This pre-specified statistical analysis plan details the methodology for the analysis of the UNITI trial results.
Trial registration
ClinicalTrials.gov NCT04663828. The trial is ongoing. Date of registration: December 11, 2020. All patients that finished their treatment before 19 December 2022 are included in the main RCT analysis. |
| Citation: |
Simoes, Jorge P. and Schoisswohl, Stefan and Schlee, Winfried and Basso, Laura and Bernal-Robledano, Alberto and Boecking, Benjamin and Cima, Rilana and Engelke, Milena and Escaler-Balsera, Alba and Gallego-Martinez, Alvaro and Gallus, Silvano and Kikidis, Dimitris and López-Escámez, Jose and Marcrum, Steven C. and Markatos, Nicolaos and Martin-Lagos, Juan and Martinez-Martinez, Marta and Mazurek, Birgit and Vassou, Evgenia and Jarach, Carlotta M. and Mueller-Locatelli, Nicolas and Neff, Patrick and Niemann, Uli and Hafez, Kader O. and Puga, Clara and Schleicher, Miro and Unnikrishnan, Vishnu and Perez-Carpena, Patricia and Pryss, Rüdiger and Robles-Bolivar, Paula and Rose, Matthias and Schecklmann, Martin and Schiele, Tabea and Schobel, Johannes and Spiliopoulou, Myra and Stark, Sabine and Vogel, Carsten and Wunder, Nina
(2023)
The statistical analysis plan for the unification of treatments and interventions for tinnitus patients randomized clinical trial (UNITI-RCT).
Trials, 24.
Article 472.
ISSN 1745-6215
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