Unification of treatments and Interventions for Tinnitus patients

Informazioni relative al progetto

UNITI

ID dell’accordo di sovvenzione: 848261

DOI

10.3030/848261

Progetto chiuso

Data della firma CE 24 Novembre 2019

Data di avvio 1 Gennaio 2020

Data di completamento 30 Settembre 2023

Finanziato da

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

Costo totale

€ 5 989 343,75

Contributo UE

€ 5 989 343,75

Coordinato da

KLINIKUM DER UNIVERSITAET REGENSBURG
Germany

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

Periodo di rendicontazione: 2023-01-01 al 2023-09-30

Sintesi del contesto e degli obiettivi generali del progetto

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.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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.
 

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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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