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

Project: EU project

Project Details


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.
Effective start/end date1/11/1930/04/25

Collaborative partners

  • VTT Technical Research Centre of Finland
  • NHS Greater Glasgow and Clyde (Project partner)
  • Leiden University Medical Center (LUMC) (Project partner)
  • European Clinical Research Infrastructure Network (ECRIN) (Project partner)
  • Stichting MLC Foundation (Project partner)
  • empirica Kommunikations- und Technologieforschung GmbH (Project partner)
  • Technologie- und Methodenplattform für die vernetzte medizinische Forschung e.V. (TMF) (Project partner)
  • Pfizer Ltd. (Project partner)
  • Associação para a Investigação e Desenvolvimento de Ciências (FCiências.ID) (Project partner)
  • Cambridge Cognition Ltd. (Project partner)
  • AbbVie Inc (Project partner)
  • University of Cambridge (Project partner)
  • University of Manchester (Project partner)
  • Pluribus One Srl (Project partner)
  • Takeda Pharmaceuticals International AG (Project partner)
  • Imperial College London (Project partner)
  • Fundación Para la Investigación Biomedica de El Hospital Clínico San Carlos (Project partner)
  • UCB BIOPHARMA (Project partner)
  • University Medical Center Schleswig-Holstein (Project partner)
  • AstraZeneca AB (Project partner)
  • Newcastle University (Project partner) (lead)
  • Stavanger University Hospital (Project partner)
  • Madrid Parkinson Association (Project partner)
  • F. Hoffmann-La Roche AG (Project partner)
  • University of Kiel (Project partner)
  • Orion Oyj (Project partner)
  • University of Limerick (Project partner)
  • Takeda Development Centre Europe Ltd. (Project partner)
  • Lixoft SAS (Project partner)
  • George-Huntington-Institut GmbH (Project partner)
  • iXscient Ltd. (Project partner)
  • Institute of Psychiatry and Neurology (IPiN) (Project partner)
  • European Federation of Crohn's & Ulcerative Colitis Associations (EFCCA) (Project partner)
  • Innsbruck Medical University (Project partner)
  • Institut Mines-Télécom (IMT) (Project partner)
  • Biogen Idec Ltd (Project partner)
  • MediBioSense Ltd (Project partner)
  • Universidade de Lisboa (Project partner)
  • McRoberts B.V. (Project partner)
  • Instituto de Medicina Molecular João Lobo Antunes (Project partner)
  • Dreem (Project partner)
  • Erasmus Medical Centre (Project partner)
  • Sanofi-Aventis Recherche et Développement S.A. (Project partner)
  • Autonomous University of Madrid (Project partner)
  • Queen Mary University of London (Project partner)
  • University of Glasgow (Project partner)
  • Eli Lilly & Co Ltd. (Project partner)
  • Parkinson's UK (Project partner)
  • Byteflies (Project partner)
  • CHDI Foundation, Inc. (Project partner)
  • University of Brescia (Project partner)
  • Koordinierungszentrum für Klinische Studien (KKS) (Project partner)
  • Janssen Pharmaceutica NV (Project partner)

Funding category

  • EU-H2020


  • H2020-JTI-IMI2-2018-15-two-stage
  • Neurological disorders (e.g. Alzheimer's disease
  • Huntington's disease
  • Parkinson's disease)