The aim of the Feasibility Study (FS) is to gather information on a variety of potential digital measures captured with different devices and their ability to reflect sleep disturbances or fatigue. The preparation phase includes the concept design of the study, the technical specifications, and assessment of the stepwise development of the study.

2 Meetings with the EMA’s Innovation Task Force (ITF) to consolidate the FS protocol, FS data analysis, COS protocol and development.  

2000 participants with a variety of neurodegenerative and immune-mediated inflammatory conditions across 22 sites are recruited and monitored for 6 months while using digital devices. The results from COS are instrumental in meeting the challenge of developing composite digital endpoints to assess fatigue and sleep disturbances.

Based on the interim data analysis, a final set of digital biomarkers is selected. These biomarkers will form the basis for further regulatory validation and potential adoption in clinical trials.

All data collected during the COS is finalized and locked to data integrity for subsequent regulatory submission and scientific analysis.