Unification of treatments and Interventions for Tinnitus patients

Project Information

UNITI

Grant agreement ID: 848261

DOI

10.3030/848261

Project closed

EC signature date 24 November 2019

Start date 1 January 2020

End date 30 September 2023

Funded under

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Total cost

€ 5 989 343,75

EU contribution

€ 5 989 343,75

Coordinated by

KLINIKUM DER UNIVERSITAET REGENSBURG
Germany

Periodic Reporting for period 3 - UNITI (Unification of treatments and Interventions for Tinnitus patients)

Reporting period: 2023-01-01 to 2023-09-30

Summary of the context and overall objectives of the project

Tinnitus, the perception of a phantom sound and the associated patient response, is a prevalent and economically burdensome condition. More than 10% of the general population is affected, and 1% consider it a major health issue. Recent studies predict a doubling of prevalence in Europe by 2050. Genetic causes have gained recent attention, revealing a heritability comparable to conditions like autism and schizophrenia. The problem of the increasing prevalence of tinnitus is exacerbated by the fact that there is no treatment that is effective for all patients.
The UNITI project addressed the complexity of tinnitus, aiming to create a predictive model for personalized treatment. The primary goal was to develop a model using diverse data types (clinical, medical, genetic, and audiological) to determine the most effective treatment for each patient, enhancing comprehension and offering personalized strategies.

The UNITI project successfully achieved significant scientific and technological milestones.
• Genetic and blood biomarkers were explored,
• candidate genes for tinnitus were identified, and a
• unified database and a
• mobile application for treatment interventions were developed.
• A randomized clinical trial was performed and yielded clinically relevant results,
• the socio-economic cost of tinnitus was assessed, and
• a Decision Support System (DSS) was created.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The UNITI project has made substantial progress in advancing our understanding and treatment of tinnitus:
The exploration of genetic and blood biomarkers associated with tinnitus resulted in the identification of potential candidate genes. Whole Genome Sequencing uncovered 38 genes with candidate variants, providing valuable insights into the genetic factors influencing tinnitus.
A unified database scheme was successfully developed and utilized in the multicenter Randomized Clinical Trial.
Moreover, the UNITI mobile app was created and translated in multiple languages for iOS and Android devices, which offers treatment (structured counselling, sound therapy) and monitoring options.
The multicenter Randomized Clinical Trial involved 461 patients and was concluded with promising results. It offered insights into effective interventions for tinnitus. Notably, the results highlighted the clinical advantage of combination treatments over single treatments. The collected and anonymized RCT data will be made publicly accessible, promoting transparency, and facilitating further research.
Moreover, a Decision Support System (DSS) for personalized tinnitus management was developed and implemented. The DSS exhibited strong performance in predicting treatment outcomes. Integrating DSS into the tinnitus database front-end fulfilled the main goal of constructing a predictive model for personalized treatment. This integration provides clinicians with an innovative and valuable tool for dynamic treatment planning, making UNITI a unique contribution to tinnitus research.
In addition, a financial estimation analysis was conducted which revealed high out-of-pocket expenditures, emphasizing the significant financial burden of tinnitus on individuals and society.

In conclusion, the UNITI project has successfully fulfilled its objectives and made significant strides in understanding and addressing the challenges posed by tinnitus. The results obtained contribute to the broader understanding of tinnitus and its socio-economic impact, contribute to a comprehensive knowledge base, and offer promising avenues for further research and advancements in tinnitus care. Moreover, by integrating various data sources and creating a predictive model, the project contributes to personalized treatment strategies, offering hope for improved outcomes in managing this complex condition.
 

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

UNITI undertook an initiative to advance tinnitus research and contribute to the well-being of the European tinnitus population in various ways.
The Progress beyond the state of the art and its impact lay mainly in developing a predictive model for personalized tinnitus treatment, utilizing existing and longitudinal data. This innovative approach aimed to identify the most effective treatment tailored to individuals based on their unique profiles. The collaborative efforts of multidisciplinary partners facilitated the rapid development and validation of UNITI's predictive models. These models hold considerable potential to enhance treatment planning and advance tinnitus care, offering hope for improved outcomes in managing this complex condition.

Another significant aspect of the UNITI project was the execution of the largest Randomized Clinical Trial (RCT) on tinnitus to date. Since tinnitus is a heterogenous condition with multiple causes, UNITI specifically applied and tested combinational treatments as an intervention against chronic tinnitus. The RCT results demonstrated a clinical benefit of this approach, offering a promising avenue for further research.

UNITI achieved notable success by reaching over 1000 patients across various studies. The UNITI app, which was developed during the project, is freely available and being utilized in other research projects for comprehensive data collection.

Emphasizing effective dissemination and communication, UNITI shared its findings through scientific publications, social media, press releases, the project website, videos, conferences, training events, and fairs. The adoption of open data principles enhances sustainability and empowers researchers to utilize and analyze UNITI datasets and tools.
To ensure the enduring impact of UNITI, a dedicated working group has been formed. This group will leverage UNITI's research, seek further exploitation opportunities, and explore additional funding avenues to advance tinnitus treatments. In conclusion, UNITI has not only achieved significant scientific milestones but has also laid the foundation for impactful and sustainable contributions to tinnitus research and treatment.

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