TY - JOUR
T1 - IDEA-FAST clinical study protocol
T2 - Identifying digital end-points of fatigue, sleep quality and daytime sleepiness in N = 2000
AU - IDEA-FAST Project Consortium
AU - Maetzler, Walter
AU - Avey, Stefan
AU - Pilotto, Andrea
AU - van der Woude, C. Janneke
AU - Lamb, Christopher A.
AU - Reilmann, Ralf
AU - Ahmaniemi, Teemu
AU - Ammour, Nadir
AU - Aufenberg, Svenja
AU - Avedano, Luisa
AU - Basu, Neil
AU - Beniston, Simon
AU - Bonomelli, Sofia
AU - de Bot, Susanne T.
AU - Branco, Diogo
AU - Bruce, Ian
AU - Bull, Christopher Neil
AU - Chareh, Neshat
AU - Chatterjee, Meenakshi
AU - Chinoy, Hector
AU - Chisholm, Jade
AU - Connolly, Hayley
AU - Cormack, Francesca
AU - Correia Guedes, Leonor
AU - Cowhig, Cliona
AU - De Sousa, Dina
AU - Del Din, Silvia
AU - Devillers, Monique
AU - Dias, Inês M.
AU - Dodds, Colin Bone
AU - Doona, Mary
AU - Dvinskis, Annika
AU - Ferreira, Joaquim J.
AU - Fourlakis, Konstantinos
AU - Funken, Ulli
AU - Goulden, Kay
AU - Graeber, Johanna
AU - Gordon, Miriam Grande
AU - Graßhoff, Hanna
AU - Guerreiro, Tiago
AU - Hagen-Hurley, Tina
AU - Hansen, Clint
AU - Harney, Sinead
AU - Hart, Ailsa
AU - Hinchliffe, Chloe
AU - Hinz, Sophia
AU - Hovsbakken, Marthe Alver
AU - Jackson, Michael
AU - John, Lauren
AU - Kennedy, Norelee
N1 - Publisher Copyright:
© The Author(s) 2026. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
PY - 2026/1/1
Y1 - 2026/1/1
N2 - 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.
AB - 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.
KW - Digital health technologies
KW - Huntington's disease
KW - immune-mediated disorders
KW - inflammatory bowel disease
KW - Parkinson's disease
UR - https://www.scopus.com/pages/publications/105034898465
U2 - 10.1177/20552076261428155
DO - 10.1177/20552076261428155
M3 - Article
AN - SCOPUS:105034898465
SN - 2055-2076
VL - 12
JO - Digital Health
JF - Digital Health
ER -