European Commission logo
español español
CORDIS - Resultados de investigaciones de la UE
CORDIS

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

Descripción del proyecto

DE EN ES FR IT PL

Identificar los criterios de evaluación digitales para la fatiga y el sueño

Los pacientes con trastornos neurodegenerativos y enfermedades inflamatorias inmunomediadas suelen padecer fatiga y trastornos del sueño. Estos dos síntomas discapacitantes conducen a una mala calidad de vida y a unos costes sanitarios elevados. Sin embargo, los enfoques existentes para evaluarlos están basados en el uso de cuestionarios y tienen unas limitaciones significativas, por lo que no son fiables y no tienen en cuenta el impacto de los tratamientos. El proyecto IDEA-FAST, financiado con fondos europeos, identificará nuevos criterios de evaluación digitales para la fatiga y los trastornos del sueño y ofrecerá una evaluación más fiable y objetiva de la gravedad y los efectos de los síntomas. El propósito del proyecto es comprender los mecanismos fundamentales de estos dos trastornos y mejorar los ensayos clínicos en previsión de nuevos tratamientos con menos costes.

Objetivo

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.

Ámbito científico

Palabras clave

Programa(s)

Tema(s)

Convocatoria de propuestas

H2020-JTI-IMI2-2018-15-two-stage

Consulte otros proyectos de esta convocatoria

Régimen de financiación

RIA - Research and Innovation action

Coordinador

UNIVERSITY OF NEWCASTLE UPON TYNE
Aportación neta de la UEn
€ 4 644 337,05
Dirección
KINGS GATE
NE1 7RU Newcastle Upon Tyne
Reino Unido

Ver en el mapa
Región
North East (England) Northumberland and Tyne and Wear Tyneside
Tipo de actividad
Higher or Secondary Education Establishments
Enlaces
Coste total
€ 5 371 912,05

Participantes (59)

Compartir esta página

Descargar

Última actualización: 8 Julio 2024

Mi folleto

Permalink: https://cordis.europa.eu/project/id/853981/es

European Union, 2024