IDEA-FAST clinical study protocol: Identifying digital end-points of fatigue, sleep quality and daytime sleepiness in N = 2000
Year: 2026
Type: article
Abstract: Background Fatigue, impaired sleep quality and daytime sleepiness, common in neurodegenerative and immune-mediated diseases, are debilitating and have serious societal and economic implications. Currently, measurement of these symptoms largely relies on self-reported questionnaires, which are burdensome for patients and lack sensitivity, granularity and reliability. Methods Building on a preceding feasibility study and qualification advice of the European Medicines Agency, the Clinical Observational Study of the European project Identifying Digital Endpoints to Assess FAtigue, Sleep and acTivities of daily living in Neurodegenerative disorders and Immune-mediated inflammatory diseases (IDEA-FAST) investigates the relationship between digital and clinical parameters of the target concepts of fatigue, reduced sleep quality and daytime sleepiness. Results Between 2022 and 2025, 2000 people are being recruited at 24 European sites – 500 with Parkinson's disease, 500 with inflammatory bowel disease, 200 with each of the following diseases: Huntington's disease, rheumatoid arthritis, systemic lupus erythematosus, primary Sjögren's syndrome and 200 healthy volunteers. Participants are followed over a 24-week period with four visits, each including a 1-week assessment phase at home using CE-certified digital health (including active and passive) technologies. The latter collect information on physical activity, physiology, cognition as well as social interaction and behaviour as core dimensions of the target concepts. Conclusion This study will help to develop reliable, valid and efficient digital endpoints of fatigue, impaired sleep quality and daytime sleepiness for use in future clinical studies and trials.
Source: Digital Health
Authors: Walter Maetzler, Stefan Avey, Andrea Pilotto, C Janneke van der Woude, Christopher A Lamb, Ralf Reilmann, Teemu Ahmaniemi, Nadir Ammour, Svenja Aufenberg, Luisa Avedano, Neil Basu, Simon Beniston, Sofia Bonomelli, Susanne T de Bot, Diogo Branco, Ian Bruce, Christopher Neil Bull, Neshat Chareh, Meenakshi Chatterjee, Hector Chinoy, Jade Chisholm, Hayley Connolly, Francesca Cormack, Leonor Correia Guedes, Cliona Cowhig, Dina De Sousa, Silvia Del Din, Monique Devillers, Inês M Dias, Colin Bone Dodds, Mary Doona, Annika Dvinskis, Joaquim J Ferreira, Konstantinos Fourlakis, Ulli Funken, Kay Goulden, Johanna Graeber, Miriam Grande Gordon, Hanna Graßhoff, Tiago Guerreiro, Tina Hagen-Hurley, Clint Hansen, Sinead Harney, Ailsa Hart, Chloe Hinchliffe, Sophia Hinz, Marthe Alver Hovsbakken, Michael Jackson, Lauren John, Hanna Kaduszkiewicz, Jérôme Kalifa, Niamh Kelly, Nick Kennedy, Norelee Kennedy, Juha M Kortelainen, Laura C. M. Kuijper, Samuel Labrecque, Yasmin Laidler, Tanja Lange, Maria Boge Lauvsnes, Jimmy K. Limdi, Ellen Lirani-Silva, Victoria Macrae, Corina Maetzler, Mayca Marín, Dario Masullo, Tania Nightingale, Alessandro Padovani, Miles Parkes, Emma Paulides, Clémence Pinaud, Zaireen Pios, Costantino Pitzalis, Alexandra Prodan, Rana Zia Ur Rehman, Gabriela Riemekasten, Andrea Rizzardi, Matthew W Roche, Lynn Rochester, Robbin Romijnders, Stefan Schreiber, Katarina Schwarzová, Christian Selinger, Klaus Seppi, Louise Stockley, Sreedhar Subramanian, Kai Sun, Nick Taptiklis, Gerlynn Tiongson, Kasper F van der Zwaan, Evert-Ben van Veen, Louise Warren, David Wenn, Grzegorz Witkowski, Alison Yarnall, Frederic Baribaud, Geert Van Gassen, Nikolay V. Manyakov, Wan-Fai Ng
Institutions: Christian-Albrechts-Universität zu Kiel, University Hospital Schleswig-Holstein, Johnson & Johnson (United States), Karolinska Institutet, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, University of Brescia, Erasmus MC, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle University, George Huntington Institute, VTT Technical Research Centre of Finland, Sanofi (France), University of Glasgow, Leiden University Medical Center, University of Lisbon, Laboratório de Sistemas Informáticos de Grande Escala, Manchester Academic Health Science Centre, University of Manchester, Centre for Epidemiology Versus Arthritis, University of Newcastle Australia, European Clinical Research Infrastructure Network, Salford Royal NHS Foundation Trust, Salford Royal Hospital, Royal Devon University Healthcare NHS Foundation Trust, University of Limerick, Cambridge Cognition (United Kingdom), Beaumont Hospital, NIHR Newcastle Biomedical Research Centre, Cork University Hospital, University of Lübeck, Parkinson's UK, St. Mark's Hospital, St Mark's Hospital, Stavanger University Hospital, iXscient, Innsbruck Medical University, Cambridge University Hospitals NHS Foundation Trust, Queen Mary University of London, Barts Health NHS Trust, William Harvey Research Institute, empirica - Communication and Technology Research, Johnson & Johnson (United Kingdom), CHDI Foundation, Leeds Teaching Hospitals NHS Trust, University of Cambridge, Imperial College London, Wojskowy Instytut Medycyny Lotniczej, Bristol-Myers Squibb (United States), Takeda (Belgium), University College Cork
Language: English
Topic: Sleep and related disorders
Subfield: Experimental and Cognitive Psychology
Field: Psychology
Domain: Social Sciences
Open Access status: gold
Estimated APC paid: $2,000
Funder: Innovative Medicines Initiative
Award: G2276986836
OpenAlex ID: W7144047068