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Identifying Digital Endpoints to Assess FAtigue, Sleep and acTivities in daily living in Neurodegenerative disorders and Immune-mediated inflammatory diseases

Project description

Identifying digital endpoints for fatigue and sleep

Patients with neurodegenerative disorders (NDD) and immune-mediated inflammatory diseases (IMID) are often affected by fatigue and sleep disturbances. These two disabling symptoms lead to poor quality of life and high healthcare costs. However, existing approaches to evaluate them are based on questionnaire methodology and have significant limitations. As a consequence, they are not reliable and do not take the impact of therapies into consideration. The EU-funded IDEA-FAST project will identify new digital endpoints for fatigue and sleep disturbances and offer a more objective and reliable evaluation of the seriousness and the effects of the symptoms. The purpose of the project is to understand the key mechanisms of these two disturbances and improve clinical trials envisaging new therapies with lower costs.


Fatigue and sleep disturbances are two common and disabling symptoms that affect patients with neurodegenerative disorders (NDD) and immune-mediated inflammatory diseases (IMID). These symptoms are major predictors of poor quality of life and increased healthcare cost. Current questionnaire-based approaches to measure these symptoms have key limitations preventing them from being used as reliable endpoints in clinical trials to evaluate the effect of therapies.

IDEA-FAST aims to address these issues by identifying novel digital endpoints for fatigue and sleep disturbances that will provide more objective, sensitive and reliable measures of the severity and impact of these symptoms in ecological settings. Such digital endpoints will not only help to gain insight into the underpinning mechanisms of fatigue and sleep disturbances, but will also vastly improve the efficiency of clinical trials, ultimately reducing the time and cost to bring new therapies to patients.

To identify these digital endpoints, we will follow the recommendations of the Clinical Trials Transformation Initiative (CTTI). We will identify the characteristics that fatigue and sleep disturbances will have impact, then select the digital measures (endpoints) to quantify them, followed by choosing the appropriate digital device/technology accordingly. We will then perform a pilot study to prioritise a few of these candidate digital endpoints for validation. We will test the performance of these digital endpoints in two NDD and four IMID in a large longitudinal study during which extensive relevant clinical data will be collected. If these digital endpoints were validated, we will seek support from EMA/FDA for their qualification. Patient users’ perspective, ethical, data privacy, legal and other regulatory issues will be taken into consideration in all aspects of our proposal.

The resultant digital biobank from the longitudinal study will become an invaluable resource for future exploitation.


Net EU contribution
€ 4 960 260,05
Kings gate
NE1 7RU Newcastle upon tyne
United Kingdom

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North East (England) Northumberland and Tyne and Wear Tyneside
Activity type
Higher or Secondary Education Establishments
Other funding
€ 27 575,00

Participants (57)