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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RIA - Research and Innovation actionCoordinator
NE1 7RU Newcastle Upon Tyne
United Kingdom
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Participants (59)
23562 Lübeck
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
24118 Kiel
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
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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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
G12 0XH Glasgow
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- Limerick
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75014 Paris
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
28040 Madrid
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
Participation ended
T12 YN60 Cork
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
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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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
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75009 Paris
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
CB2 1TN Cambridge
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92160 Antony
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
28014 Madrid
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
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3521 AL Utrecht
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
10117 Berlin
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DN9 2PG Doncaster
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
53111 Bonn
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
1749 016 Lisbon
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
1749-016 Lisboa
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09128 Cagliari
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
1649 028 Lisboa
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02150 Espoo
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CB25 9TU Cambridge
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
28049 Madrid
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91120 Palaiseau
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2596HN 's-Gravenhage (Den Haag)
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
48149 Munster
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
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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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
1000 Bruxelles / Brussel
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2333 ZA Leiden
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M13 9PL Manchester
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Legal entity other than a subcontractor which is affiliated or legally linked to a participant. The entity carries out work under the conditions laid down in the Grant Agreement, supplies goods or provides services for the action, but did not sign the Grant Agreement. A third party abides by the rules applicable to its related participant under the Grant Agreement with regard to eligibility of costs and control of expenditure.
Participation ended
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.
10001 New York
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Participation ended
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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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
3521 AL Utrecht
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The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.
10154 New York
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T12 YN60 Cork
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