IDEA-FAST clinical study protocol: Identifying digital end-points of fatigue, sleep quality and daytime sleepiness in N=2000, 2026, Maetzler

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First published online March 31, 2026
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IDEA-FAST clinical study protocol: Identifying digital end-points of fatigue, sleep quality and daytime sleepiness in N = 2000​

Walter Maetzler
https://orcid.org/0000-0002-5945-4694 w.maetzler@neurologie.uni-kiel.de,



https://journals.sagepub.com/doi/10.1177/20552076261428155

Walter Maetzler https://orcid.org/0000-0002-5945-4694 w.maetzler@neurologie.uni-kiel.de, Stefan Avey https://orcid.org/0000-0003-2768-4337, […] IDEA-FAST Project Consortium+97View all authors and affiliations

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.

 

[Utsikt]

They only use one week intervals for the digital health tracking (DHT). I’m not sure if that’s enough.

A total of 24 European sites are involved. The study started in June 2022 and the planned overall study duration is 41 months. A total of four clinical study visits, accompanied by a DHT use period of 7 days, respectively, are planned for every participant (see next paragraphs for details). The first DHT use period includes a run-in phase of 3 days. The individual mean study duration is 24 weeks. The DHT use periods are always in the usual environment of the participant.

The outcomes look very interesting, though, and might be useful for ME/CFS studies. There are apps that track your typing on smartphones, and patches that have accelerometers, tracks vital signs, posture, etc. There’s also a bed sensor.