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Lookup NU author(s): Professor Chris LambORCiD, Dr Christopher BullORCiD, Dr Silvia Del DinORCiD, Mary Doona, Dr Chloe Hinchliffe, Victoria Macrae, Professor Lynn RochesterORCiD, Professor Alison YarnallORCiD, Professor Fai Ng
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).
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.
Author(s): Maetzler W, Avey S, Pilotto A, van der Woude CJ, Lamb CA, Reilmann R, Ahmaniemi T, Ammour N, Aufenberg S, Avedano L, Basu N, Beniston S, Bonomelli S, de Bot ST, Branco D, Bruce I, Bull CN, Chareh N, Chatterjee M, Chinoy H, Chisholm J, Connolly H, Cormack F, Guedes LC, Cowhig C, De Sousa D, Del Din S, Devillers M, Dias IM, Dodds CB, Doona M, Dvinskis A, Ferreira JJ, Fourlakis K, Funken U, Goulden K, Graeber J, Gordon MG, Graßhoff H, Guerreiro T, Hagen-Hurley T, Hansen C, Harney S, Hart A, Hinchliffe C, Hinz S, Hovsbakken MA, Jackson M, John L, Kaduszkiewicz H, Kalifa J, Kelly N, Kennedy N, Kennedy N, Kortelainen JM, Kuijper LCM, Labrecque S, Laidler Y, Lange T, Lauvsnes MB, Limdi JK, Lirani-Silva E, Macrae V, Maetzler C, Marín M, Masullo D, Nightingale T, Padovani A, Parkes M, Paulides E, Pinaud C, Pios Z, Pitzalis C, Prodan A, Rehman RZU, Riemekasten G, Rizzardi A, Roche MW, Rochester L, Romijnders R, Schreiber S, Schwarzová K, Selinger C, Seppi K, Stockley L, Subramanian S, Sun K, Taptiklis N, Tiongson G, van der Zwaan KF, van Veen EB, Warren L, Wenn D, Witkowski G, Yarnall A, Baribaud F, Van Gassen G, Manyakov NV, Ng WF, IDEA-FAST PC
Publication type: Article
Publication status: Published
Journal: DIGITAL HEALTH
Year: 2026
Volume: 12
Online publication date: 31/03/2026
Acceptance date: 11/02/2026
Date deposited: 11/05/2026
ISSN (print): 2055-2076
ISSN (electronic): 2055-2076
Publisher: Sage Publications Ltd
URL: https://doi.org/10.1177/20552076261428155
DOI: 10.1177/20552076261428155
Data Access Statement: A study protocol is described here. Data collection of this study has already started and results will be presented in future publications.
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