Unification of Treatments and Interventions for Tinnitus Patients - UNITI

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.

 

2. KUL 500pxOne 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. 

KU Leuven (Leuven, Belgium) is an institution for research and education with international appeal. All programs at this University are based on the innovative research of its scientists and professors. KU Leuven ranks among the best 50 universities worldwide and is 7th most innovative university (Reuters)! 

TMS Team 29 01 2020

The Tinnituscenter of the University of Regensburg was established in 2007 as a result of an intensive multidisciplinary collaboration of the ENT- and Audiological Department and the Department for Psychiatry and Psychotherapy. This collaboration was established in a common research project aiming to explore brain stimulation as a potential treatment for tinnitus.

Over the years more and more disciplines were involved. All patients receive a comprehensive multidisciplinary diagnostic assessment and the treatment options comprise patient education, cognitive behavioural therapy, sound therapies, pharmacotherapy and different forms of brain stimulation.

Since 2007 more than 3500 patients have been treated at the Tinnituscenter of the University of Regensburg. All data from these patients have been systematically assessed and provide the basis for a large international clinical database.

CCM Althoffhaus 01 500pxProf. Dr. Birgit Mazurek.smile 500pxa

One 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 the 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 Charité. As one of the largest university hospitals in Europe, all of Charité’s clinical care, research and teaching is delivered by physicians and researchers of the highest international standard. Charité proudly lays claim to more than half of all German Nobel Prize winners in Physiology or Medicine, including Emil von Behring, Robert Koch and Paul Ehrlich.

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UNITI Clinical Trial

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Study start is planned for Jan 2021.

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