Unification of Treatments and Interventions for Tinnitus Patients - UNITI


The outbreak of coronavirus/COVID-19 throughout Europe and worldwide continues to cause great concern, uncertainty, and anxiety among all of us. Therefore, we extend our best health and safety wishes accross all borders, to everyone affected, all indivduals, families, institutions, countries, and regions.

Our thoughts are especially with our partners in Italy, Spain, and Germany, and everyone else included.

We hope for a swift passing of this international crisis, with the least impact to global health and economy possible.

Especially in this extraordinary situation, we realise how special, vital, strong and fruitful our international cooperation is, and we strive for it to continue, to the benefit of tinnitus research and tinnitus patients in Europe and beyond.

The UNITI consortium.

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On February 14, 2020, the database and mobile app team of UNITI met in Würzburg. Myra Spiliopoulou, Miro Schleicher, Vishnu Unnikrishnan (OVGU Magdeburg), Eleftheria Velidou, ICCS Athens, Rüdiger Pryss and Carsten Vogel (University Hospital Wuerzburg) discussed first steps of the database as well as app unification issues. The Team was also joined by Ioannis Basdekis from the FORTH-ICS, Greece (via Skype). Additional meetings will follow soon.

On February 19, 2020, UNITI staff member Axel Schiller gladly followed the invitation of Medical Valley EMN e. V. Erlangen, a corporation of renowned experts in medical device design and regulation, to learn about the clinical evaluation of medical device software.

We greatly benefited, since the UNITI consortium, and especially our partners at the University of Würzburg (Prof Rüdiger Pryss), are already working intensively on the programming of new apps for tinnitus patients, to be used within the framework of our large randomised-controlled trial, starting early next year!

We are immensely grateful for this opportunity, and are very much looking forward to collaborating more with Medical Valley in the course of our pan-European project!

Schulung Wrzburg HolfelderThe mobile apps for patient-centered research used in the study conducted in UNITI will be developed according to the principles of the Medizinproduktegesetz MPG and the new EU Medical Device Regulation MDR. At the invitation of the Chair of Clinical Epidemiology and Biometry of the Medical Faculty of the University of Würzburg, Winny Schlee and Axel Schiller from Regensburg took part in the training course "Normgerechte Softwareentwicklung im international regulierten Umfeld (DE, EU, USA)" (Standard-compliant software development in an internationally regulated environment (DE, EU; USA)), in which Marc Holfelder (LA2 GmbH), member of the external UNITI Advisory Board, who presented the most important regulatory aspects of the MPG with regard to software development to the UNITI partners from Regensburg and Würzburg.

GRA_team.jpgOne of the main objectives of UNITI is to conduct a large scale multicentre Randomised Clinical Trial (RCT) with a combination of interventions. Five clinical centres (partners of UNITI consortium) will have a target of recruiting 100 patients each over a period of 9 months.

One of the UNITI’s clinical centre is the The Andalusian Health ServiceThe Andalusian Health Service or Servicio Andaluz de Salud (SAS) is the government-run health system for the autonomous community of Andalusia (Spain). The SAS serves a population of 8,302,923 inhabitants and employs 95,000 healthcare professionals distributed in 1,500 Primary care centers and 44 public hospitals. The Health Research Institute of Granada or “Instituto de Investigación Biosanitaria de Granada” (ibs.GRANADA) is an excellent multicenter health research hub that clusters the biomedical research groups at the Hospital Virgen de las Nieves (HVN), Hospital Clínico San Cecilio (HSC) and Universidad de Granada. Both hospitals are among the largest hospitals in the Public Health System of Andalusia (SSPA), equipped with a highly complex portfolio of services and state-of-the-art equipment for diagnosis and treatment. With a workforce of more than 7,600 professionals and the incorporation of advanced technologies, they testify to a balance between available resources and the developed activity. HVN and HSC will recruit patients to conduct the tinnitus clinical trial.

 

UNITI Clinical Trial

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