Clinical Protocol for the IDEA-FAST Study: Assessing Digital Metrics of Fatigue, Sleep Quality, and Daytime Sleepiness in a Cohort of 2000 Participants - Scorecard - MDSpire

Clinical Protocol for the IDEA-FAST Study: Assessing Digital Metrics of Fatigue, Sleep Quality, and Daytime Sleepiness in a Cohort of 2000 Participants

  • By

  • Walter Maetzler

  • Stefan Avey

  • Andrea Pilotto

  • C Janneke van der Woude

  • Christopher A Lamb

  • Ralf Reilmann

  • Teemu Ahmaniemi

  • Nadir Ammour

  • Svenja Aufenberg

  • Luisa Avedano

  • Neil Basu

  • Simon Beniston

  • Sofia Bonomelli

  • Susanne T de Bot

  • Diogo Branco

  • Ian Bruce

  • Christopher Neil Bull

  • Neshat Chareh

  • Meenakshi Chatterjee

  • Hector Chinoy

  • Jade Chisholm

  • Hayley Connolly

  • Francesca Cormack

  • Leonor Correia Guedes

  • Cliona Cowhig

  • Dina De Sousa

  • Silvia Del Din

  • Monique Devillers

  • Inês M Dias

  • Colin Bone Dodds

  • Mary Doona

  • Annika Dvinskis

  • Joaquim J Ferreira

  • Konstantinos Fourlakis

  • Ulli Funken

  • Kay Goulden

  • Johanna Graeber

  • Miriam Grande Gordon

  • Hanna Graßhoff

  • Tiago Guerreiro

  • Tina Hagen-Hurley

  • Clint Hansen

  • Sinead Harney

  • Ailsa Hart

  • Chloe Hinchliffe

  • Sophia Hinz

  • Marthe Alver Hovsbakken

  • Michael Jackson

  • Lauren John

  • Hanna Kaduszkiewicz

  • Jérôme Kalifa

  • Niamh Kelly

  • Nick Kennedy

  • Norelee Kennedy

  • Juha M Kortelainen

  • Laura C. M. Kuijper

  • Samuel Labrecque

  • Yasmin Laidler

  • Tanja Lange

  • Maria Boge Lauvsnes

  • Jimmy K. Limdi

  • Ellen Lirani-Silva

  • Victoria Macrae

  • Corina Maetzler

  • Mayca Marín

  • Dario Masullo

  • Tania Nightingale

  • Alessandro Padovani

  • Miles Parkes

  • Emma Paulides

  • Clémence Pinaud

  • Zaireen Pios

  • Costantino Pitzalis

  • Alexandra Prodan

  • Rana Zia Ur Rehman

  • Gabriela Riemekasten

  • Andrea Rizzardi

  • Matthew W Roche

  • Lynn Rochester

  • Robbin Romijnders

  • Stefan Schreiber

  • Katarina Schwarzová

  • Christian Selinger

  • Klaus Seppi

  • Louise Stockley

  • Sreedhar Subramanian

  • Kai Sun

  • Nick Taptiklis

  • Gerlynn Tiongson

  • Kasper F van der Zwaan

  • Evert-Ben van Veen

  • Louise Warren

  • David Wenn

  • Grzegorz Witkowski

  • Alison Yarnall

  • Frederic Baribaud

  • Geert Van Gassen

  • Nikolay V. Manyakov

  • Wan-Fai Ng

  • IDEA-FAST Project Consortium

  • March 1, 2026

  • 0 min

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Clinical Scorecard: Clinical Protocol for the IDEA-FAST Study: Assessing Digital Metrics of Fatigue, Sleep Quality, and Daytime Sleepiness in a Cohort of 2000 Participants

At a Glance

CategoryDetail
ConditionFatigue, impaired sleep quality, and daytime sleepiness in neurodegenerative and immune-mediated disorders
Key MechanismsChanges in biophysiology, cognitive performance, physical performance, and social behaviour associated with fatigue and sleep disturbances
Target PopulationPeople with Parkinson's disease, Huntington's disease, inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, primary Sjögren's syndrome, and healthy volunteers
Care SettingMultinational observational clinical study across 24 European sites in participants' usual living environments

Key Highlights

  • Fatigue, impaired sleep quality, and daytime sleepiness are common and impactful symptoms across multiple chronic neurodegenerative and immune-mediated diseases.
  • Current self-reported questionnaires lack sensitivity and reliability to capture symptom fluctuations; digital health technologies offer continuous monitoring possibilities.
  • The IDEA-FAST study aims to identify objective, scalable digital endpoints for fatigue, sleep quality, and daytime sleepiness to improve clinical trial assessments.

Guideline-Based Recommendations

Diagnosis

  • Use digital health technology-derived parameters to monitor biophysiological, cognitive, physical, and social dimensions related to fatigue and sleep disturbances.
  • Incorporate continuous or semi-continuous monitoring in natural living environments to capture symptom fluctuations.

Management

  • Develop treatments guided by objective digital intermediate clinical endpoints identified through the IDEA-FAST study.
  • Utilize digital biomarkers to enhance assessment accuracy and reliability in clinical trials.

Monitoring & Follow-up

  • Conduct repeated digital health technology use periods of 7 days with a 3-day run-in phase at multiple time points during the study.
  • Monitor participants in their usual environment to capture real-world symptom dynamics.

Risks

  • No specific risks detailed; ethical approvals and adherence to the Declaration of Helsinki are ensured.
  • Potential burden minimized by using digital monitoring rather than frequent self-report questionnaires.

Patient & Prescribing Data

2000 participants including patients with PD, HD, IBD, RA, SLE, PSS, and healthy volunteers

Data will inform development of digital biomarkers to improve treatment evaluation and monitoring of fatigue, sleep quality, and daytime sleepiness.

Clinical Best Practices

  • Employ digital health technologies to capture multidimensional symptom data continuously or semi-continuously.
  • Design studies with adequate sample sizes to enable machine learning-based biomarker identification and robust psychometric evaluation.
  • Ensure ethical compliance and participant monitoring in naturalistic settings to enhance data validity.

References

Original Source(s)

Clinical Protocol for the IDEA-FAST Study: Assessing Digital Metrics of Fatigue, Sleep Quality, and Daytime Sleepiness in a Cohort of 2000 Participants

  • by Walter Maetzler, Stefan Avey, Andrea Pilotto, C Janneke van der Woude, Christopher A Lamb, Ralf Reilmann, Teemu Ahmaniemi, Nadir Ammour, Svenja Aufenberg, Luisa Avedano, Neil Basu, Simon Beniston, Sofia Bonomelli, Susanne T de Bot, Diogo Branco, Ian Bruce, Christopher Neil Bull, Neshat Chareh, Meenakshi Chatterjee, Hector Chinoy, Jade Chisholm, Hayley Connolly, Francesca Cormack, Leonor Correia Guedes, Cliona Cowhig, Dina De Sousa, Silvia Del Din, Monique Devillers, Inês M Dias, Colin Bone Dodds, Mary Doona, Annika Dvinskis, Joaquim J Ferreira, Konstantinos Fourlakis, Ulli Funken, Kay Goulden, Johanna Graeber, Miriam Grande Gordon, Hanna Graßhoff, Tiago Guerreiro, Tina Hagen-Hurley, Clint Hansen, Sinead Harney, Ailsa Hart, Chloe Hinchliffe, Sophia Hinz, Marthe Alver Hovsbakken, Michael Jackson, Lauren John, Hanna Kaduszkiewicz, Jérôme Kalifa, Niamh Kelly, Nick Kennedy, Norelee Kennedy, Juha M Kortelainen, Laura C. M. Kuijper, Samuel Labrecque, Yasmin Laidler, Tanja Lange, Maria Boge Lauvsnes, Jimmy K. Limdi, Ellen Lirani-Silva, Victoria Macrae, Corina Maetzler, Mayca Marín, Dario Masullo, Tania Nightingale, Alessandro Padovani, Miles Parkes, Emma Paulides, Clémence Pinaud, Zaireen Pios, Costantino Pitzalis, Alexandra Prodan, Rana Zia Ur Rehman, Gabriela Riemekasten, Andrea Rizzardi, Matthew W Roche, Lynn Rochester, Robbin Romijnders, Stefan Schreiber, Katarina Schwarzová, Christian Selinger, Klaus Seppi, Louise Stockley, Sreedhar Subramanian, Kai Sun, Nick Taptiklis, Gerlynn Tiongson, Kasper F van der Zwaan, Evert-Ben van Veen, Louise Warren, David Wenn, Grzegorz Witkowski, Alison Yarnall, Frederic Baribaud, Geert Van Gassen, Nikolay V. Manyakov, Wan-Fai Ng, IDEA-FAST Project Consortium

  • March 1, 2026

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