November 2019 - August 2020
Feasibility Study Preparation
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.
Clinical Observation Study Preparation
Results from the FS are used to develop the plan for the COS: the design of the study, specifications regarding participant recruitment and device usage, data collection, and data analysis.
Clinical Observation Study
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.