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Towards a unification of treatments and interventions for tinnitus patients: The EU research and innovation action UNITI

2021; Elsevier BV; Linguagem: Inglês

10.1016/bs.pbr.2020.12.005

1875-7855

Winfried Schlee, Stefan Schoisswohl, Susanne Staudinger, Axel Schiller, Astrid Lehner, Berthold Langguth, Martin Schecklmann, Jorge Simões, Patrick Neff, Steven C. Marcrum, Myra Spiliopoulou, Uli Niemann, Miro Schleicher, Vishnu Unnikrishnan, Clara Puga, Lena Mulansky, Ruediger Pryss, Carsten Vogel, Johannes Allgaier, Efi Giannopoulou, Katalin Birki, Klairi Liakou, Rilana Cima, Johan W.S. Vlaeyen, Nicolas Verhaert, Saskia Ranson, Birgit Mazurek, Petra Brüeggemann, Benjamin Boecking, Nyamaa Amarjargal, Sandy Specht, A. Stege, Michael Hummel, Matthias Rose, Kevin Oppel, Juliane Dettling-Papargyris, José A. López‐Escámez, Sana Amanat, Álvaro Gallego-Martinez, Alba Escalera‐Balsera, Juan Manuel Espinosa‐Sanchez, Juan Carlos García‐Valdecasas, Maria Mata-Ferron, Juan Martin-Lagos, María Martínez-Martínez, María Jesús Martinez-Martinez, Nicolás Müller Locatelli, Patricia Perez‐Carpena, Jorge Alcazar-Beltran, Leyre Hidalgo-Lopez, Eleftheria Vellidou, Michail Sarafidis, Panagiotis Katrakazas, Vassileia Kostaridou, Dimitris Koutsouris, Ourania Manta, Evangelos Paraskevopoulos, Maria Haritou, Ana Belén Elgoyhen, Hazel Goedhart, Michael Koller, Giriraj Singh Shekhawat, Holger Crump, Ronny Hannemann, Marc Holfelder, Timon Oberholzer, Apóstolos Vontas, Ilias Trochidis, Vasiliki Moumtzi, Christopher R. Cederroth, Konstantina Koloutsou, George Spanoudakis, Ioannis Basdekis, Silvano Gallus, Alessandra Lugo, Chiara Stival, Elisa Borroni, Nikolaos Markatos, Athanasios Bibas, Dimitris Kikidis,

Noise Effects and Management

Tinnitus is the perception of a phantom sound and the patient's reaction to it. Although much progress has been made, tinnitus remains a scientific and clinical enigma of high prevalence and high economic burden, with an estimated prevalence of 10%–20% among the adult population. The EU is funding a new collaborative project entitled “Unification of Treatments and Interventions for Tinnitus Patients” (UNITI, grant no. 848261) under its Horizon 2020 framework. The main goal of the UNITI project is to set the ground for a predictive computational model based on existing and longitudinal data attempting to address the question of which treatment or combination of treatments is optimal for a specific patient group based on certain parameters. Clinical, epidemiological, genetic and audiological data, including signals reflecting ear-brain communication, as well as patients' medical history, will be analyzed making use of existing databases. Predictive factors for different patient groups will be extracted and their prognostic relevance validated through a Randomized Clinical Trial (RCT) in which different patient groups will undergo a combination of tinnitus therapies targeting both auditory and central nervous systems. From a scientific point of view, the UNITI project can be summarized into the following research goals: (1) Analysis of existing data: Results of existing clinical studies will be analyzed to identify subgroups of patients with specific treatment responses and to identify systematic differences between the patient groups at the participating clinical centers. (2) Genetic and blood biomarker analysis: High throughput Whole Exome Sequencing (WES) will be performed in well-characterized chronic tinnitus cases, together with Proximity Extension Assays (PEA) for the identification of blood biomarkers for tinnitus. (3) RCT: A total of 500 patients will be recruited at five clinical centers across Europe comparing single treatments against combinational treatments. The four main treatments are Cognitive Behavioral Therapy (CBT), hearing aids, sound stimulation, and structured counseling. The consortium will also make use of e/m-health applications for the treatment and assessment of tinnitus. (4) Decision Support System: An innovative Decision Support System will be implemented, integrating all available parameters (epidemiological, clinical, audiometry, genetics, socioeconomic and medical history) to suggest specific examinations and the optimal intervention strategy based on the collected data. (5) Financial estimation analysis: A cost-effectiveness analysis for the respective interventions will be calculated to investigate the economic effects of the interventions based on quality-adjusted life years. In this paper, we will present the UNITI project, the scientific questions that it aims to address, the research consortium, and the organizational structure.