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 specific objectives of UNITI are:

  1. To investigate genetic and blood biomarkers related to tinnitus.
  2. To develop a unified database schema containing demographical, epidemiological, audiological, electrophysiological and medical history data, validated questionnaires, real time data collected from e/m-health applications and treatment progression features.
  3. To develop an interventional mobile application, able to map tinnitus characteristics (e.g. frequency, intensity), produce individualized masking and music therapy (using filters in audio files uploaded by the patient) and record data in real time from each patient.
  4. To conduct a multicentre Randomised Clinical Trial (RCT) with a combination of interventions, including Cognitive Behavioural Treatment (CBT), Sound therapy, Structured Counselling and Hearing Aid fitting. 
  5. To formulate the multilevel concept of the UNITI platform, by integrating all available parameters (epidemiological, clinical, laboratory, genetics and socioeconomic) , in a user-friendly Decision Support System (DSS) as a front-end, able to suggest specific examinations according to individual patient’s profile and optimal treatment strategy based on the sum of collected data.
  6. To analyse the RCT results using sophisticated tools, taking into account detailed profiling of participants in correlation with results of Objectives 1 and 5.
  7. Development of the first in-silico models, bridging cochlea and central auditory pathway with use of electrophysiological methods, which will provide auditory stimulus and collect responses up to the level of brainstem and cortex. The models will be utilised in order to improve personalised interventions, such as music/sound therapy.
  8. To conduct a financial estimation analysis.

UNITI Clinical Trial

Are you Tinnitus patient and interested in participating?

Study start is planned for Jan 2021.

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