Major IDEA-FAST Milestone Achieved!
Recruitment for the Clinical Observational Study (COS) is now complete, reaching 1891 participants across 20 sites in 10 European countries. This marks a major step towards identifying digital biomarkers that can transform how we measure fatigue and sleep disturbances — moving from subjective questionnaires to continuous, real-world digital assessments.
The IDEA-FAST COS, building on the earlier feasibility study, will generate one of the most extensive, comprehensive datasets of its kind, combining:
- Clinical and patient-reported outcomes
- Digital sensor data from wearables and home-based devices
- Biological samples from a subgroup
Together, these provide a robust foundation for developing objective, patient-centred digital biomarkers with applications in clinical research, regulatory science, and future healthcare innovation.
“This was one of the most challenging and fulfilling research tasks we have ever undertaken”, agreed Corina Maetzler, the COS study manager, and Walter Maetzler, the chief clinical investigator, both from the University Hospital Schleswig-Holstein and Kiel University, Germany.
“This is a remarkable success considering the complexity of the study and the involvement of multiple sites across Europe. The resultant dataset of this study comprising biophysiological, neurocognitive, behavioural, clinical and patient –reported outcomes is highly valuable and unique, which will not only be useful for achieving our project objectives but also to support a wide range of future research” said Fai Ng, IDEA-FAST coordinator.
“This milestone provides the comprehensive, real‑world dataset required to develop and validate digital biomarkers that can generate objective, reliable endpoints — accelerating clinical trials while making them more patient‑centred and cost‑efficient” remarked IDEA-FAST industry lead Nikolay Manyakov.
We thank all our participants, clinical teams, and partners across Europe for making this possible! Next stop: the data analysis phase, translating rich digital data into insights that will drive the future of fatigue and sleep management.