Unification of treatments and Interventions for Tinnitus patients

Resultado final

The final exploitation sustainability and business plans and activities of UNITI partners

Report on Gender and Equal Opportunities

This deliverable will provide sexdisaggregated data on the project workforce on the impact of the working environment and on the career and professional mobility

Midterm Recruitment Report

The Midterm Recruitment Report will summarize the recruitment progress at the half time of the clinical trial

Dissemination and communication Plan

This report will include the overall project dissemination and communication strategy and planning, and a description of the main promotional material and tools that will be used. It will include a comprehensive set of dissemination elements including: logo, banner, flyer, brochure, poster, official short description, the project website plus the entire social network that will be used to advertise the activities of the project. Dissemination material will be edited in English and the languages of all partners involved.

Report on legal and ethical issues monitoring

This deliverable will cover all issues described in Task 15 of the proposalWithin this Task the legal and ethical issues throughout the whole duration of the project will be monitored In addition a data privacy framework will be developed that covers the internal processing of personal data within the project including the following ethical and legal aspects i Patients specific voluntary explicit and informed consent ii evaluation and analysis of specific broad and tiered consent especially for genetic samples iii procedures for withdrawing consent iv appropriate anonymisation and pseudonymisation techniques v lawful use processing transfer storage access of sensitive healthrelated data vi potential liabilities vii accordance with GDPR viii feedback process for individuals ix regulatory issues and related EU as well as national legislation x establishment of collecting and shipping procedures

Analysis of medical adherence on existing m-health data

The deliverable will mainly report on1 predictors of medical adherence and2 phenotypes associated to medical adherence

Report on status of posting results

The results of the clinical trial need to be posted in a publicly available clinical trial registry This deliverable will need to report about the successful public posting of the results

Final report on RCT, Dissemination, communication and community building

This deliverable will be a final document summarizing the results of the RCT the UNITI dissemination activities communication and community building activities

UNITI Health socio-economic impact analysis

The deliverable aims to report on the socio-economic impact factors of tinnitus to health care and society in Europe.Furthermore it will evaluate the effect of the UNITI treatment and intervention on the health-care costs. A health economic model of tinnitus will be created.

First study subject approvals package

The first study subject approvals package will contain the documents about the ethics approvals for the clinical trial at all centers.

Exploitation Plan and innovation management report

Present the innovation management and exploitation strategy and activities of partners It will describe the business cases for the different stakeholders

UNITI's Ensemble-based prediction models

The deliverable will report on ensemble mechanisms that combine i models derived with the WP3 methods from the clinicspecific data ii models derived from the Layer 2 data a dedicated voting scheme will be built to this purpose This voting scheme will take into account the distribution of the phenotypes identified in the tasks of layer 2 inside each clinic Next to predictions on outcome predictions on medical adherence will also be supported

Data management plan

The deliverable will outline how the scientific data will be handled during the project and after the project.

Creation of the project website

The UNITI website will be online before M3 of the project. The deliverable will officially report about this.

Publicaciones

UNITI Mobile—EMI-Apps for a Large-Scale European Study on Tinnitus

Autores: Carsten Vogel; Johannes Schobel; Winfried Schlee; Milena Engelke; Rüdiger Pryss
Publicado en: 43rd Annual International Conference of the IEEE Engineering in Medicine & Biology Society (EMBC), 2021
Editor: IEEE
DOI: 10.1109/embc46164.2021

Predicting the optimal therapeutic intervention for tinnitus patients using random forest regression: A preliminary study of UNITI's decision support system model

Autores: Konstantinos Bromis, Michail Sarafidis, Ourania Manta, Ioannis Kouris, Eleftheria Vellidou, Winfried Schlee, and Dimitrios Koutsouris
Publicado en: 44th Annual International Conference of the IEEE Engineering in Medicine & Biology Society (EMBC), 2022
Editor: IEEE
DOI: 10.1109/embc48229.2022.9871331

Prediction of declining engagement to self-monitoring apps on the example of tinnitus mHealth data.

Autores: Schleicher, M., Hamacher, S., Naujoks, M., Günther, K., Schmidt, T., Pryss, R., ... & Spiliopoulou, M.
Publicado en: 2022 IEEE 35th International Symposium on Computer-Based Medical Systems (CBMS), 2022
Editor: IEEE
DOI: 10.1109/cbms55023.2022.00047

Circadian Conditional Granger Causalities on Ecological Momentary Assessment Data from an mHealth App

Autores: Noor Jamaludeen, Vishnu Unnikrishnan, Ruediger Pryss, Johannes Schobel, Winfried Schlee, Myra Spiliopoulou
Publicado en: 2021 IEEE 34th International Symposium on Computer-Based Medical Systems (CBMS), 2021, Página(s) 354-359, ISBN 978-1-6654-4121-6
Editor: IEEE
DOI: 10.1109/cbms52027.2021.00110

Electrophysiological differences in distinct hearing threshold level individuals with and without tinnitus distress

Autores: Ourania Manta; Michail Sarafidis; Winfried Schlee; Christos Consoulas; Dimitrios Kikidis; Dimitrios Koutsouris
Publicado en: 44th Annual International Conference of the IEEE Engineering in Medicine & Biology Society (EMBC), 2022
Editor: IEEE
DOI: 10.1109/embc48229.2022.9871392

Autores: Unnikrishnan, V., Schleicher, M., Puga, C., Pryss, R., Vogel, C., Schlee, W., & Spiliopoulou, M.
Publicado en: Advances in Intelligent Data Analysis XXI: 21st International Symposium on Intelligent Data Analysis, IDA 2023, Louvain-la-Neuve, Belgium, April 12–14, 2023, Proceedings, 2023
Editor: Springer-Verlag
DOI: 10.1007/978-3-031-30047-9_36

Expect the gap: A recommender approach to estimate the absenteeism of self-monitoring mHealth app users

Autores: Schleicher, M., Pryss, R., Schobel, J., Schlee, W., & Spiliopoulou, M.
Publicado en: 2022 IEEE 9th International Conference on Data Science and Advanced Analytics (DSAA), Edición 2022, 2022, Página(s) 1-10
Editor: IEEE
DOI: 10.1109/dsaa54385.2022.10032390

When can I expect the mHealth user to return? Prediction meets time series with gaps.

Autores: Schleicher, M., Pryss, R., Schlee, W., & Spiliopoulou, M.
Publicado en: Artificial Intelligence in Medicine: International Conference on Artificial Intelligence in Medicine. Proceedings, Edición 2022, 2022, ISBN 978-3-031-09341-8
Editor: Springer-Verlag
DOI: 10.1007/978-3-031-09342-5_30

Predicting Patient-Based Time-Dependent Mobile Health Data.

Autores: Kleinau, A., Fluegel, S., Pryss, R., Vogel, C., Engelke, M., Schlee, W., Unnikrishnan, V., & Spiliopoulou, M.
Publicado en: 2023 IEEE 36th International Symposium on Computer-Based Medical Systems (CBMS), 2023
Editor: IEEE
DOI: 10.1109/cbms58004.2023.00196

Discovery of Patient Phenotypes through Multi-layer Network Analysis on the Example of Tinnitus

Autores: Clara Puga, Uli Niemann, Vishnu Unnikrishnan, Miro Schleicher, Winfried Schlee, and Myra Spiliopoulou
Publicado en: 2021, ISBN 978-1-6654-2099-0
Editor: IEEE
DOI: 10.1109/dsaa53316.2021.9564158

Why a Clinical Decision Support System is needed for Tinnitus?

Autores: Sarafidis, M., Manta, O., Kouris, I., Schlee, W., Kikidis, D., Vellidou, E., & Koutsouris, D.
Publicado en: 43rd Annual International Conference of the IEEE Engineering in Medicine & Biology Society (EMBC), 2021
Editor: IEEE
DOI: 10.1109/embc46164.2021.9630137

The Effect of Environmental Stressors on Tinnitus: A Prospective Longitudinal Study on the Impact of the COVID-19 Pandemic

Autores: Winfried Schlee, Sondre Hølleland, Jan Bulla, Jorge Simoes, Patrick Neff, Stefan Schoisswohl, Stella Woelflick, Martin Schecklmann, Axel Schiller, Susanne Staudinger, Thomas Probst, Berthold Langguth
Publicado en: Journal of Clinical Medicine, Edición 9/9, 2020, Página(s) 2756, ISSN 2077-0383
Editor: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/jcm9092756

Prediction of Tinnitus Perception Based on Daily Life MHealth Data Using Country Origin and Season

Autores: Johannes Allgaier, Winfried Schlee, Thomas Probst and Rüdiger Pryss
Publicado en: Journal of Clinical Medicine, 2022, ISSN 2077-0383
Editor: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/jcm11154270

Technological Advances in the Diagnosis and Management of Tinnitus

Autores: Patricia Perez-Carpena; Jose Antonio Lopez-Escamez
Publicado en: Crossref, Edición 3, 2022, ISSN 2077-0383
Editor: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/jcm11154597

Burden of rare variants in synaptic genes in patients with severe tinnitus: An exome based extreme phenotype study

Autores: Sana Amanat, Alvaro Gallego-Martinez, Joseph Sollini, Patricia Perez-Carpena, Juan M. Espinosa-Sanchez, Ismael Aran, Andres Soto-Varela, Angel Batuecas‐Caletrio, Barbara Canlon, Patrick May, Christopher R. Cederroth, Jose A. Lopez-Escamez
Publicado en: EBioMedicine, 2021, ISSN 2352-3964
Editor: Elsevier BV
DOI: 10.1016/j.ebiom.2021.103309

Smartphone-Guided Educational Counseling and Self-Help for Chronic Tinnitus

Autores: Winfried Schlee, Patrick Neff, Jorge Simoes, Berthold Langguth, Stefan Schoisswohl, Heidi Steinberger, Marie Norman, Myra Spiliopoulou, Johannes Schobel, Ronny Hannemann and Rüdiger Pryss
Publicado en: Journal of Clinical Medicine, 2022, ISSN 2077-0383
Editor: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/jcm11071825

Standardized Clinical Profiling in Spanish Patients with Chronic Tinnitus

Autores: Elisheba Haro-Hernandez, Patricia Perez-Carpena, Vishnu Unnikrishnan, Myra Spiliopoulou and Jose A. Lopez-Escamez
Publicado en: Journal of Clinical Medicine, 2022, ISSN 2077-0383
Editor: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/jcm11040978

Juxtaposing Medical Centers Using Different Questionnaires Through Score Predictors.

Autores: Puga C, Schleicher M, Niemann U, Unnikrishnan V, Boecking B, Brueggemann P, Simoes J, Langguth B, Schlee W, Mazurek B, Spiliopoulou M.
Publicado en: Front Neurosci., Edición 16, 2022, Página(s) 818686, ISSN 1662-453X
Editor: Lausanne: Frontiers Media S.A.
DOI: 10.3389/fnins.2022.818686

The Effect of Non-Personalised Tips on the Continued Use of Self-Monitoring mHealth Applications

Autores: Vishnu Unnikrishnan, Miro Schleicher, Yash Shah, Noor Jamaludeen, Ruediger Pryss, Johannes Schobel, Robin Kraft, Winfried Schlee, Myra Spiliopoulou
Publicado en: Brain Sciences, Edición 10/12, 2020, Página(s) 924, ISSN 2076-3425
Editor: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/brainsci10120924

Sex-Dependent Aggregation of Tinnitus in Swedish Families

Autores: Natalia Trpchevska, Jan Bulla, Matilda Prada Hellberg, Niklas K. Edvall, Andra Lazar, Golbarg Mehraei, Inger Uhlen, Winfried Schlee, Barbara Canlon, Silvano Gallus, Jose Antonio Lopez-Escamez, Christopher R. Cederroth
Publicado en: Journal of Clinical Medicine, Edición 9/12, 2020, Página(s) 3812, ISSN 2077-0383
Editor: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/jcm9123812

Using coding and non-coding rare variants to target candidate genes in patients with severe tinnitus.

Autores: Gallego-Martinez A, Escalera-Balsera A, Trpchevska N et al.
Publicado en: NPJ Genom Med, Edición 7/1, 2022, ISSN 2056-7944
Editor: Springer Nature
DOI: 10.1038/s41525-022-00341-w

Systematic Review on Healthcare and Societal Costs of Tinnitus

Autores: Ilias Trochidis, Alessandra Lugo, Elisa Borroni, Christopher R. Cederroth, Rilana Cima, Dimitris Kikidis, Berthold Langguth, Winfried Schlee, Silvano Gallus
Publicado en: International Journal of Environmental Research and Public Health, Edición 18/13, 2021, Página(s) 6881, ISSN 1660-4601
Editor: International Journal of Environmental Research and Public Health
DOI: 10.3390/ijerph18136881

Association between Hyperacusis and Tinnitus

Autores: Christopher R. Cederroth, Alessandra Lugo, Niklas K. Edvall, Andra Lazar, Jose-Antonio Lopez-Escamez, Jan Bulla, Inger Uhlen, Derek J. Hoare, David M. Baguley, Barbara Canlon, Silvano Gallus
Publicado en: Journal of Clinical Medicine, Edición 9/8, 2020, Página(s) 2412, ISSN 2077-0383
Editor: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/jcm9082412

Methodological Aspects of Randomized Controlled Trials for Tinnitus: A Systematic Review and How a Decision Support System Could Overcome Barriers

Autores: Dimitrios Kikidis, Evgenia Vassou, Winfried Schlee, Eleftheria Iliadou, Nikolaos Markatos, Aikaterini Triantafyllou, Berthold Langguth
Publicado en: Journal of Clinical Medicine, Edición 10/8, 2021, Página(s) 1737, ISSN 2077-0383
Editor: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/jcm10081737

Global Prevalence and Incidence of TinnitusA Systematic Review and Meta-analysis

Autores: Carlotta M Jarach, Alessandra Lugo, Marco Scala, Piet A van den Brandt, Christopher R Cederroth, Anna Odone, Werner Garavello, Winfried Schlee, Berthold Langguth, Silvano Gallus
Publicado en: JAMA Neurol, 2022, ISSN 2168-6149
Editor: American Medical Association
DOI: 10.1001/jamaneurol.2022.2189

Understanding adherence to the recording of ecological momentary assessments in the example of tinnitus monitoring

Autores: Miro Schleicher, Vishnu Unnikrishnan, Patrick Neff, Jorge Simoes, Thomas Probst, Rüdiger Pryss, Winfried Schlee, Myra Spiliopoulou
Publicado en: Scientific Reports, Edición 10/1, 2020, ISSN 2045-2322
Editor: Nature Publishing Group
DOI: 10.1038/s41598-020-79527-0

Hearing Aid Fitting in Tinnitus: A Scoping Review of Methodological Aspects and Effect on Tinnitus Distress and Perception

Autores: Dimitrios Kikidis; Evgenia Vassou; Nikolaos Markatos; Winfried Schlee; Eleftheria Iliadou
Publicado en: Journal of Clinical Medicine, Edición 1, 2021, ISSN 2077-0383
Editor: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/jcm10132896

Pilot study of a smartphone-based tinnitus therapy using structured counseling and sound therapy: A multiple-baseline design with ecological momentary assessment

Autores: Milena Engelke, Jorge Simões, Carsten Vogel, Stefan Schoisswohl, Martin Schecklmann, Stella Wölflick, Rüdiger Pryss, Thomas Probst, Berthold Langguth, Winfried Schlee
Publicado en: PLOS Digit Health, 2023, ISSN 1932-6203
Editor: Public Library of Science
DOI: 10.1371/journal.pdig.0000183

Predicting the gender of individuals with tinnitus based on daily life data of the TrackYourTinnitus mHealth platform.

Autores: Allgaier, J., Schlee, W., Langguth, B., Probst, T., & Pryss, R.
Publicado en: Scientific Reports, Edición 11/1, 2021, ISSN 2045-2322
Editor: Nature Publishing Group
DOI: 10.1038/s41598-021-96731-8

Predicting Ecological Momentary Assessments in an App for Tinnitus by Learning From Each User's Stream With a Contextual Multi-Armed Bandit

Autores: Saijal Shahania, Vishnu Unnikrishnan, Rüdiger Pryss, Robin Kraft, Johannes Schobel, Ronny Hannemann, Winny Schlee and Myra Spiliopoulou
Publicado en: Front. Neurosc Sec. Auditory Cognitive Neuroscience, 2022, ISSN 1662-4548
Editor: Frontiers Research Foundation
DOI: 10.3389/fnins.2022.836834

A cost-based multi-layer network approach for the discovery of patient phenotypes

Autores: Clara Puga; Uli Niemann; Winfried Schlee; Myra Spiliopoulou
Publicado en: International Journal of Data Science and Analytics, 2023, ISSN 2364-4168
Editor: Springer Nature
DOI: 10.1007/s41060-023-00431-7

Unification of Treatments and Interventions for Tinnitus Patients (UNITI): a study protocol for a multi-center randomized clinical trial

Autores: Stefan Schoisswohl, Berthold Langguth, Martin Schecklmann, Alberto Bernal-Robledano, Benjamin Boecking, Christopher R. Cederroth, Dimitra Chalanouli, Rilana Cima, Sam Denys, Juliane Dettling-Papargyris, Alba Escalera-Balsera, Juan Manuel Espinosa-Sanchez, Alvaro Gallego-Martinez, Efi Giannopoulou, Leyre Hidalgo-Lopez, Michael Hummel, Dimitris Kikidis, Michael Koller, Jose A. Lopez-Escamez, Steven
Publicado en: Trials, 2021, ISSN 1745-6215
Editor: BioMed Central
DOI: 10.1186/s13063-021-05835-z

Development and Evaluation of Automated Tools for Auditory-Brainstem and Middle-Auditory Evoked Potentials Waves Detection and Annotation

Autores: Ourania Manta, Michail Sarafidis, Nikolaos Vasileiou, Winfried Schlee, Christos Consoulas, Dimitris Kikidis, Evgenia Vassou, George K. Matsopoulos and Dimitrios D. Koutsouris
Publicado en: Brain Sciences, 2022, ISSN 2076-3425
Editor: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/brainsci12121675

Development of Machine-Learning Models for Tinnitus-Related Distress Classification Using Wavelet-Transformed Auditory Evoked Potential Signals and Clinical Data.

Autores: Manta, O., Sarafidis, M., Schlee, W., Mazurek, B., Matsopoulos, G. K., and Koutsouris, D. D.
Publicado en: J. Clin. Med., Edición 12/11, 2022, ISSN 2077-0383
Editor: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/jcm12113843

The statistical analysis plan for the unification of treatments and interventions for tinnitus patients randomized clinical trial (UNITI-RCT)

Autores: Simoes, J.P., Schoisswohl, S., Schlee, W. et al.
Publicado en: Trials, Edición 24/472, 2023, ISSN 1745-6215
Editor: BioMed Central
DOI: 10.1186/s13063-023-07303-2

The Impact of COVID-19 Confinement on Tinnitus and Hearing Loss in Older Adults: Data From the LOST in Lombardia Study

Autores: Carlotta Micaela Jarach, Alessandra Lugo, Chiara Stival, Cristina Bosetti, Andrea Amerio3,4, Luca Cavalieri d'Oro5, Licia Iacoviello6,7, Anna Odone8,9, David Stuckler10, Alberto Zucchi11, Piet van den Brandt12,13, Werner Garavello14, Christopher R. Cederroth15,16,17, Winfried Schlee18, Silvano Gallus1* and the LOST in Lombardia Study Investigators
Publicado en: Frontiers in Neurology, Sec. Neuro-Otology, 2022, ISSN 1664-2295
Editor: Frontiers Research Foundation
DOI: 10.3389/fneur.2022.838291

Interactive System for Similarity-Based Inspection and Assessment of the Well-Being of mHealth Users

Autores: Subash Prakash, Vishnu Unnikrishnan, Rüdiger Pryss, Robin Kraft, Johannes Schobel, Ronny Hannemann, Berthold Langguth, Winfried Schlee and Myra Spiliopoulou
Publicado en: Entropy, Edición 23/12, 2021, ISSN 1099-4300
Editor: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/e23121695

Low Sleep Satisfaction Is Related to High Disease Burden in Tinnitus

Autores: Franziska C. Weber, Winfried Schlee, Berthold Langguth, Martin Schecklmann, Stefan Schoisswohl, Thomas C. Wetter and Jorge Simões
Publicado en: International Journal of Environmental Research and Public Health, 2022, ISSN 1661-7827
Editor: Multidisciplinary Digital Publishing Institute (MDPI)
DOI: 10.3390/ijerph191711005

Genome-wide association meta-analysis identifies 48 risk variants and highlights the roleof the stria vascularis in hearing loss

Autores: Natalia Trpchevska, Maxim B Freidin, Linda Broer, Berthe C Oosterloo, Shuyang Yao, Yitian Zhou, Barbara Vona, Charles Bishop, Argyro Bizaki-Vallaskangas, Barbara Canlon, Fabio Castellana, Daniel I Chasman, Stacey Cherny, Kaare Christensen, Maria Pina Concas, Adolfo Correa, Ran Elkon, Estonian Biobank Research Team, Jonas Mengel-From, Yan Gao, Anne B S Giersch, Giorgia Girotto, Alexander Gudjonsson
Publicado en: The American Journal of Human Genetics, 2022, ISSN 1537-6605
Editor: American journal of human genetics
DOI: 10.1016/j.ajhg.2022.04.010

Genetic Inheritance and Its Contribution to Tinnitus.

Autores: Amanat S, Gallego-Martinez A, Lopez-Escamez JA.
Publicado en: Curr Top Behav Neurosci, Edición 51, 2021, Página(s) 29-47, ISBN 978-3-030-85503-1
Editor: Springer Cham
DOI: 10.1007/7854_2020_155

Towards a unification of treatments and interventions for tinnitus patients: The EU research and innovation action UNITI

Autores: Winfried Schlee, Stefan Schoisswohl, Susanne Staudinger, Axel Schiller, Astrid Lehner, Berthold Langguth, Martin Schecklmann, Jorge Simoes, Patrick Neff, Steven C. Marcrum, Myra Spiliopoulou, Uli Niemann, Miro Schleicher, Vishnu Unnikrishnan, Clara Puga, Lena Mulansky, Ruediger Pryss, Carsten Vogel, Johannes Allgaier, Efi Giannopoulou, Katalin Birki, Klairi Liakou, Rilana Cima, Johan W.S. Vlaeyen,
Publicado en: Tinnitus - An Interdisciplinary Approach Towards Individualized Treatment: From Heterogeneity to Personalized Medicine, Edición 260, 2021, Página(s) 441-451, ISBN 9780128215869
Editor: Elsevier
DOI: 10.1016/bs.pbr.2020.12.005

Using Big Data to Develop a Clinical Decision Support System for Tinnitus Treatment

Autores: Winfried Schlee, Berthold Langguth, Rüdiger Pryss, Johannes Allgaier, Lena Mulansky, Carsten Vogel, Myra Spiliopoulou, Miro Schleicher, Vishnu Unnikrishnan, Clara Puga, Ourania Manta, Michalis Sarafidis, Ioannis Kouris, Eleftheria Vellidou, Dimitris Koutsouris, Konstantina Koloutsou, George Spanoudakis, Christopher Cederroth, Dimitris Kikidis
Publicado en: Current Topics in Behavioral Neurosciences, 2021
Editor: Springer Berlin Heidelberg
DOI: 10.1007/7854_2021_229

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