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

Are you a Parkinson's, or Huntington's patient, or suffer from Inflammatory Bowel Disease, Rheumatoid Arthritis, Lupus, or Sjogren's Syndrome? Then you might be eligible to participate in our study.

IDEA-FAST Timeline

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.

July 2020 - May 2021

Feasibility Study

Recruitment of participants across 6 diseases cohorts in four clinical sites, device usage data collection, and biomarker evaluation. The FS outcomes are integral in the development and optimisation of the Clinical Observation Study (COS).

2020 - 2022

EMA Interactions

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

May 2021 - April 2022

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.

April 2022 - August 2024

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.

April 2025

Final Data Package

Showcase project outputs and other disseminations, and presentation of the finalised data package to obtain scientific advice and approval from the EMA/FDA.

Latest News

New Paper Published on Fatigue and Sleep Assessment through Digital Wearables

January 13, 2023

Our newly published research presents results on using wearable sensing technology to assess fatigue and sleep in patients with chronic diseases. The article provides clinicians with insights on monitoring patients in the natural everyday settings

#1 Newsletter of the IDEA-FAST COS

November 2, 2022

Dear readers, The Clinical Observation Study (COS) is on a roll, and we are proud to present the first Newsletter of the IDEA-FAST COS, with the latest recruitment status. The COS is an ambitious study

University of Glasgow recruited their first participant in the Clinical Observation Study

October 19, 2022

We are delighted to announce that University of Glasgow has recruited their first participant in the IDEA-FAST Clinical Observation Study. So far 13 sites opened for recruitment and 7 more are expected to soon join!

Devon and Exter NHS started recruitment in the Clinical Observation Study

October 5, 2022

We have great news! Devon and Exter NHS started the recruitment of participants in the Clinical Observation Study of the IDEA-FAST project, joining the other clinical sites that are now on a roll. We congratulate

Stavanger University recruited their first patient in the Clinical Observation Study

September 12, 2022

The IDEA-FAST Clinical Observation Study is on a roll! We are proud to announce that Stavanger University recruited last week their first patient and they are ready to start. We are looking forward to one

Newcastle University Begins Recruitment for Clinical Observation Study

August 17, 2022

We are delighted to announce that Newcastle University has recruited two patients for the start of the IDEA-FAST Clinical Observation Study. The goal of the study and indeed the IDEA-FAST project is to identify, profile

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Upcoming events

June 22, 2023

From BITS to BETTER. Workshop on meaningful patient engagement in developing digital endpoints in research and disease management

Berlin, Germany

July 9, 2023

ISPGR World Congress 2023

Brisbane, Australia

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 853981. The JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA and PARKINSON’S DISEASE SOCIETY OF THE UNITED KINGDOM LBG.