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.
Objective
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.
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Multi-annual funding programmes that define the EU’s priorities for research and innovation.
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H2020-EU.3.1. - SOCIETAL CHALLENGES - Health, demographic change and well-being
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H2020-EU.3.1.7. - Innovative Medicines Initiative 2 (IMI2)
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(opens in new window) H2020-JTI-IMI2-2018-15-two-stage
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NE1 7RU Newcastle Upon Tyne
United Kingdom
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Participants (59)
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23562 Lübeck
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24118 Kiel
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23562 Lubeck
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25121 Brescia
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3015 GD Rotterdam
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G12 8QQ Glasgow
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G12 0XH Glasgow
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- Limerick
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75014 Paris
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28040 Madrid
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Participation ended
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T12 YN60 Cork
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10559 BERLIN
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E1 4NS LONDON
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SW7 2AZ London
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2600 ANTWERPEN
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75009 Paris
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CB2 1TN CAMBRIDGE
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92160 ANTONY
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28014 Madrid
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3521 AL Utrecht
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The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
10117 Berlin
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DN9 2PG DONCASTER
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The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
53111 BONN
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
1749 016 Lisbon
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1749-016 Lisboa
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09134 CAGLIARI
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1649-035 LISBOA
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02150 Espoo
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CB25 9TU CAMBRIDGE
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28049 MADRID
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91120 Palaiseau
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2596HN 's-Gravenhage (Den Haag)
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
48149 MUNSTER
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
02 957 Warszawa
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6020 INNSBRUCK
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4011 STAVANGER
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TW1 4JX Twickenham Middlesex
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Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
1000 Bruxelles / Brussel
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2333 ZA Leiden
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M13 9PL Manchester
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M13 9WL MANCHESTER
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2340 Beerse
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Legal entity established in a non-associated third country that is not eligible for funding under Article 10 of the Regulation (EU) No 1290/2013 laying down the rules for participation and dissemination in Horizon 2020.
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10001 New York
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WC2B 4AE London
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60064 NORTH CHICAGO IL
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151 85 Sodertaelje
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RG21 4FA BASINGSTOKE
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SW1V 1EJ London
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CT13 9NJ Sandwich
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4070 Basel
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94250 Gentilly
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1070 Bruxelles / Brussel
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SL6 3AY Maidenhead
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02200 Espoo
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8152 Glattpark
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92160 ANTONY
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3521 AL Utrecht
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10154 New York
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The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.
Net EU financial contribution. The sum of money that the participant receives, deducted by the EU contribution to its linked third party. It considers the distribution of the EU financial contribution between direct beneficiaries of the project and other types of participants, like third-party participants.
T12 YN60 Cork
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The total costs incurred by this organisation to participate in the project, including direct and indirect costs. This amount is a subset of the overall project budget.