Unification of treatments and Interventions for Tinnitus patients

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.

Within the second reporting period, the UNITI consortium published 42 peer-reviewed publications, which can be found here: https://uniti.tinnitusresearch.net/index.php/research/scientific-publications

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

Work package 2, Project Coordination: During the second project period, the project management team ensured well-organized communication between consortium partners, monitored scientific progress, and ensured that it proceeded without major delays.

Work package 3, Analysis of Existing Data: In the second project period, clinical data analysis of existing data was performed that led to the identification of patient phenotypes, and an empirical study was conducted on the socio-economic cost of tinnitus.

Work package 4, Harmonization of Technical Solutions: The UNITI smartphone app which had been developed during the first project period was maintained and updated during the second period.

Work package 5, Intelligent Data Analysis: Algorithms which had been developed during the first project period have been applied during the second project period to predict medical adherence and treatment success of the RCT. The development of the clinical decision support system is ongoing.

Work package 6, Genetics: In the second project period, more genetic results using already existing data were published. The blood collection of 308 participants has been completed as well as the sequencing of 245 samples. First genetic analyses of the RCT participants are being performed.

Work package 7, Randomized Clinical Trial: The data collection of the randomized clinical trial has been completed on December 19, 2022. The study protocol has been published and the statistical analysis plan has been submitted. The main analysis of the RCT data has started.

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. In the second project period, an exploitation and sustainability strategy has been developed.

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.

Periodic Reporting for period 2 - UNITI (Unification of treatments and Interventions for Tinnitus patients)

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