IDEA-FAST clinical study protocol: Identifying digital end-points of fatigue, sleep quality and daytime sleepiness in N = 2000.
Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Maetzler Walter, Avey Stefan, Pilotto Andrea, van der Woude C Janneke, Lamb Christopher A, Reilmann Ralf, Ahmaniemi Teemu, Ammour Nadir, Aufenberg Svenja, Avedano Luisa, Basu Neil, Beniston Simon, Bonomelli Sofia, de Bot Susanne T, Branco Diogo, Bruce Ian, Bull Christopher Neil, Chareh Neshat, Chatterjee Meenakshi, Chinoy Hector, Chisholm Jade, Connolly Hayley, Cormack Francesca, Correia Guedes Leonor, Cowhig Cliona, De Sousa Dina, Del Din Silvia, Devillers Monique, Dias Inês M, Dodds Colin Bone, Doona Mary, Dvinskis Annika, Ferreira Joaquim J, Fourlakis Konstantinos, Funken Ulli, Goulden Kay, Graeber Johanna, Gordon Miriam Grande, Graßhoff Hanna, Guerreiro Tiago, Hagen-Hurley Tina, Hansen Clint, Harney Sinead, Hart Ailsa, Hinchliffe Chloe, Hinz Sophia, Hovsbakken Marthe Alver, Jackson Michael, John Lauren, Kaduszkiewicz Hanna, Kalifa Jérôme, Kelly Niamh, Kennedy Nick, Kennedy Norelee, Kortelainen Juha M, Kuijper Laura C M, Labrecque Samuel, Laidler Yasmin, Lange Tanja, Lauvsnes Maria Boge, Limdi Jimmy K, Lirani-Silva Ellen, Macrae Victoria, Maetzler Corina, Marín Mayca, Masullo Dario, Nightingale Tania, Padovani Alessandro, Parkes Miles, Paulides Emma, Pinaud Clémence, Pios Zaireen, Pitzalis Costantino, Prodan Alexandra, Rehman Rana Zia Ur, Riemekasten Gabriela, Rizzardi Andrea, Roche Matthew W, Rochester Lynn, Romijnders Robbin, Schreiber Stefan, Schwarzová Katarina, Selinger Christian, Seppi Klaus, Stockley Louise, Subramanian Sreedhar, Sun Kai, Taptiklis Nick, Tiongson Gerlynn, van der Zwaan Kasper F, van Veen Evert-Ben, Warren Louise, Wenn David, Witkowski Grzegorz, Yarnall Alison, Baribaud Frederic, Gassen Geert Van, Manyakov Nikolay V, Ng Wan-Fai, IDEA-FAST Project Consortium
Аннотация
METHODS: Building on a preceding feasibility study and qualification advice of the European Medicines Agency, the Clinical Observational Study of the European project Identifying Digital Endpoints to Assess FAtigue, Sleep and acTivities of daily living in Neurodegenerative disorders and Immune-mediated inflammatory diseases (IDEA-FAST) investigates the relationship between digital and clinical parameters of the target concepts of fatigue, reduced sleep quality and daytime sleepiness.
RESULTS: Between 2022 and 2025, 2000 people are being recruited at 24 European sites - 500 with Parkinson's disease, 500 with inflammatory bowel disease, 200 with each of the following diseases: Huntington's disease, rheumatoid arthritis, systemic lupus erythematosus, primary Sjögren's syndrome and 200 healthy volunteers. Participants are followed over a 24-week period with four visits, each including a 1-week assessment phase at home using CE-certified digital health (including active and passive) technologies. The latter collect information on physical activity, physiology, cognition as well as social interaction and behaviour as core dimensions of the target concepts.
CONCLUSION: This study will help to develop reliable, valid and efficient digital endpoints of fatigue, impaired sleep quality and daytime sleepiness for use in future clinical studies and trials.