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Unification of treatments and Interventions for Tinnitus patients

Periodic Reporting for period 1 - UNITI (Unification of treatments and Interventions for Tinnitus patients)

Reporting period: 2020-01-01 to 2021-07-31

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. It affects more than 10% of the general population, whereas 1% of the population considers tinnitus their major health issue.

Recent cohort studies show that tinnitus prevalence tends to increase over time and with older age. Assuming that there is no cure to be found, the prevalence estimates in Europe would double by 2050. A large variety of patient characteristics - including genotyping, aetiology, and phenotyping - are poorly understood, because integrated systems approaches are still missing to correlate patient`s characteristics to predict responses to combinatorial therapies.

Although genetic causes of tinnitus have been neglected for decades, recent findings of genetic analysis in specific subgroups (gender and phenotype) have highlighted that bilateral tinnitus in men reached a heritability of 0.68. This heritability is close to autism, schizophrenia and Attention Deficit Hyperactive Disorder (ADHD). There is no current consensus on tinnitus treatment.

UNITI’s overall aim is to deliver a predictive computational model based on existing and longitudinal data attempting to address the question which treatment approach is optimal for a specific patient based on specific parameters. Clinical, epidemiological, medical, genetic and audiological data, including signals reflecting ear-brain communication, will be analysed from existing databases. Predictive factors for different patient groups will be extracted and their prognostic relevance will be tested in a randomized controlled trial (RCT) in which different groups of patients will undergo a combination of therapies targeting the auditory and central nervous systems.
The UNITI project started officially on January 1, 2020. The kick-off meeting of the project was held in Athens, from January 15-17, 2020.

The work within the work packages during the first period is summarized below.

Work Package 1, Ethic requirements: All important ethical requirements for conducting the clinical trials, and for ensuring data security and data protections were completed and documented in the first period of the project.

Work package 2, Project Coordination: During the first project period, the tasks in this work package concentrated on setting up a well-organized communication between consortium partner that allows efficient work even during the pandemic, developing and installing quality and risk management measures, ensure the timely conduction of the tasks and documentation.

Work package 3, Analysis of Existing Data: In the first project period, we implemented a unified data collection scheme for the clinical trial, and set up the infrastructure for an efficient data processing after the data collection is completed. In addition, the needed statistical models were already developed and applied to the already existing, historical data.

Work package 4, Harmonization of Technical Solutions: As task of this work package we developed the UNITI smartphone app with different modules that can be used in the clinical study.

Work package 5, Intelligent Data Analysis: During the first period we developed predictors for medical adherence and treatment success.

Work package 6, Genetics: Preparatory actions for the Whole Exome Sequencing, and the biomarker analysis were done during the first period of the project. First genetic results have already been published, using already existing data.

Work package 7, Randomized Clinical Trial: The randomized clinical trial was prepared and started during the first project period. The first patient was included on April 16, 2021.

Work package 8, Dissemination, Communication and Exploitation: From the beginning of the project, the UNITI communication strategy was implemented and documented to inform tinnitus researchers, clinicians, patients and the society about the project and the scientific results. Furthermore, an exploitation and sustainability strategy is developed. Within the first reporting period, the UNITI consortium published 16 peer-reviewed publications, which can be found here:
UNITI aims for an impactful and beneficial contribution to the field of tinnitus research and the European population and their health, well-being and quality of life in several ways.

By implementing the largest RCT on tinnitus as of yet, the ambition of UNITI is to produce the first predictive model for personalised tinnitus treatment based on existing and longitudinal data attempting to address the question of which treatment approach is optimal, based on individual patient’s profile. The multidisciplinary profile of the contributing partners, employing state-of-the-art instrumentation and approaches, will contribute to a quick development and validation of the described predictive models of UNITI. Furthermore, the proposed solution aims to significantly reduce the number of tinnitus-related visits and as such the necessary health care resources, improving the immense socio-economic burden of this chronic condition.

For the first time, there will be a large-scale analysis of combinational therapies, which can be understand as a totally new approach to tinnitus treatment. By combining different treatment approaches with different mechanisms of action, we aim to tackle different targets of the auditory system simultaneously. Combinational therapies are a powerful tool to address medical conditions that have several causes. Since tinnitus is a heterogenous condition with multiple causes - and also multiple causes can co-exist in one individual patient - UNITI specifically aims to apply and test combinational treatments as an intervention against chronic tinnitus.