IDEA-FAST clinical study protocol: Identifying digital end-points of fatigue, sleep quality and daytime sleepiness in N = 2000

Digital Health, vol. 12, pp. 20552076261428155

Abstract

Background Fatigue, impaired sleep quality and daytime sleepiness, common in neurodegenerative and immune-mediated diseases, are debilitating and have serious societal and economic implications. Currently, measurement of these symptoms largely relies on self-reported questionnaires, which are burdensome for patients and lack sensitivity, granularity and reliability. 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.

Authors 99

1. Walter Maetzler

   Christian-Albrechts-Universität zu Kiel · University Hospital Schleswig-Holstein

   Affiliation as printed

   University Hospital Schleswig-Holstein and Kiel University

2. Stefan Avey

   Johnson & Johnson (United States)

   Affiliation as printed

   Johnson & Johnson

3. Andrea Pilotto

   Karolinska Institutet · Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · University of Brescia

   Affiliation as printed

   Department of Continuity of Care and Frailty, ASST Spedali Civili Brescia Hospital, Brescia, Italy

   Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society (NVS), Center for Alzheimer Research, Karolinska Institutet, Stockholm, Sweden

   University of Brescia

4. C. Janneke van der Woude

   Erasmus MC

   Affiliation as printed

   Erasmus University Medical Centre

5. Christopher Andrew Lamb

   Newcastle upon Tyne Hospitals NHS Foundation Trust · Newcastle University

   Affiliation as printed

   Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK

   Newcastle University

6. Ralf Reilmann

   George Huntington Institute

   Affiliation as printed

   George-Huntington-Institute, Münster, Germany

7. T. Ahmaniemi

   VTT Technical Research Centre of Finland

   Affiliation as printed

   VTT Technical Research Centre of Finland Ltd

8. Nadir Ammour

   Sanofi (France)

   Affiliation as printed

   Sanofi R&D

9. Svenja Aufenberg

   George Huntington Institute

   Affiliation as printed

   George-Huntington-Institute, Münster, Germany

10. Luisa Avedano
    Affiliation as printed

    European Federation of Crohn's and Ulcerative Colitis, Brussels, Belgium

11. Neil Basu

    University of Glasgow

    Affiliation as printed

    College of Medical, Veterinary & Life Sciences, University of Glasgow

12. Simon Beniston
    Affiliation as printed

    MediBioSense Ltd Haxey, England, UK

13. Sofia Bonomelli

    Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · University of Brescia

    Affiliation as printed

    Department of Continuity of Care and Frailty, ASST Spedali Civili Brescia Hospital, Brescia, Italy

    University of Brescia

14. Susanne Tamara de Bot Aachen

    Leiden University Medical Center

    Affiliation as printed

    Leiden University Medical Center

15. Diogo Branco

    University of Lisbon · Laboratório de Sistemas Informáticos de Grande Escala

    Affiliation as printed

    LASIGE

    Universidade de Lisboa

16. Ian N Bruce

    Manchester Academic Health Science Centre · University of Manchester · Centre for Epidemiology Versus Arthritis

    Affiliation as printed

    Centre for Epidemiology Versus Arthritis, The University of Manchester

    Manchester Academic Health Science Centre

    Manchester University Hospitals NHS Foundation Trust

17. Christopher Bull

    University of Newcastle Australia · Newcastle University

    Affiliation as printed

    Open Lab, School of Computing, Newcastle University

18. Neshat Chareh

    European Clinical Research Infrastructure Network

    Affiliation as printed

    European Clinical Research Infrastructure Network

19. Meenakshi Chatterjee

    Johnson & Johnson (United States)

    Affiliation as printed

    Johnson & Johnson

20. Hector Chinoy

    Manchester Academic Health Science Centre · Salford Royal NHS Foundation Trust · University of Manchester · Salford Royal Hospital

    Affiliation as printed

    Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK

    Manchester Academic Health Science Centre

    Salford Royal Hospital

21. Jade Megan Chisholm

    Royal Devon University Healthcare NHS Foundation Trust

    Affiliation as printed

    Royal Devon University Healthcare NHS Foundation Trust

22. Hayley Connolly

    University of Limerick

    Affiliation as printed

    and Health Research Institute, University of Limerick

23. Francesca K Cormack

    Cambridge Cognition (United Kingdom)

    Affiliation as printed

    Cambridge Cognition

24. Leonor Correia Guedes

    University of Lisbon

    Affiliation as printed

    Faculdade de Medicina da Universidade de Lisboa

25. Cliona Cowhig

    Beaumont Hospital

    Affiliation as printed

    Beaumont Hospital

26. Dina De Sousa
    Affiliation as printed

    European Huntington's Association, Lisbon, Portugal

27. Silvia Del Din

    NIHR Newcastle Biomedical Research Centre · Newcastle University

    Affiliation as printed

    National Institute for Health and Care Research (NIHR) Newcastle Biomedical Research Centre, Newcastle University, Newcastle upon Tyne, UK

    Newcastle University

28. Monique Devillers

    Erasmus MC

    Affiliation as printed

    Erasmus University Medical Centre

29. Inês Maia Dias

    University of Lisbon

    Affiliation as printed

    Faculdade de Medicina da Universidade de Lisboa

30. Colin Bone Dodds

    University of Newcastle Australia · Newcastle University

    Affiliation as printed

    Open Lab, School of Computing, Newcastle University

31. Mary Doona

    Newcastle upon Tyne Hospitals NHS Foundation Trust · Newcastle University

    Affiliation as printed

    Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK

    Newcastle University

32. Annika Dvinskis

    Cork University Hospital

    Affiliation as printed

    Cork University Hospital

33. Joaquim José Ferreira

    University of Lisbon

    Affiliation as printed

    Faculdade de Medicina da Universidade de Lisboa

34. Konstantinos Fourlakis

    University Hospital Schleswig-Holstein · University of Lübeck

    Affiliation as printed

    University Hospital Schleswig-Holstein and University of Lübeck

35. Ulli Funken

    Parkinson's UK

    Affiliation as printed

    Parkinson's UK

36. Kay Goulden

    Manchester Academic Health Science Centre · Salford Royal NHS Foundation Trust · University of Manchester · Salford Royal Hospital

    Affiliation as printed

    Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK

    Manchester Academic Health Science Centre

    Salford Royal Hospital

37. Johanna Graeber

    Christian-Albrechts-Universität zu Kiel · University Hospital Schleswig-Holstein

    Affiliation as printed

    Institute of General Medicine, University Hospital Schleswig-Holstein, Kiel University

38. Miriam Grande Gordon
    Affiliation as printed

    Asociación Parkinson Madrid (APM), Madrid, Spain

39. Hanna Graßhoff

    University Hospital Schleswig-Holstein · University of Lübeck

    Affiliation as printed

    University Hospital Schleswig-Holstein and University of Lübeck

40. Tiago Guerreiro

    University of Lisbon · Laboratório de Sistemas Informáticos de Grande Escala

    Affiliation as printed

    LASIGE

    Universidade de Lisboa

41. Tina Hagen-Hurley

    Christian-Albrechts-Universität zu Kiel · University Hospital Schleswig-Holstein

    Affiliation as printed

    University Hospital Schleswig-Holstein and Kiel University

42. Clint Hansen

    Christian-Albrechts-Universität zu Kiel · University Hospital Schleswig-Holstein

    Affiliation as printed

    University Hospital Schleswig-Holstein and Kiel University

43. S. M. J. Harney

    Cork University Hospital

    Affiliation as printed

    Cork University Hospital

44. Ailsa L Hart

    St. Mark's Hospital · St Mark's Hospital

    Affiliation as printed

    St Marks Hospital

45. Chloe H. L. Hinchliffe

    Newcastle University

    Affiliation as printed

    Newcastle University

46. Sophia Hinz

    Christian-Albrechts-Universität zu Kiel · University Hospital Schleswig-Holstein

    Affiliation as printed

    University Hospital Schleswig-Holstein, Kiel University

47. Marthe Alver Hovsbakken

    Stavanger University Hospital

    Affiliation as printed

    Stavanger University Hospital

48. Michael Jackson

    iXscient

    Affiliation as printed

    iXscient Ltd, Twickenham, UK

49. Lauren John

    Royal Devon University Healthcare NHS Foundation Trust

    Affiliation as printed

    Royal Devon University Healthcare NHS Foundation Trust

50. Hanna Kaduszkiewicz

    Christian-Albrechts-Universität zu Kiel · University Hospital Schleswig-Holstein

    Affiliation as printed

    Institute of General Medicine, University Hospital Schleswig-Holstein, Kiel University

51. Jérôme Kalifa
    Affiliation as printed

    Let It Care, Paris, France

52. Niamh Kelly

    Cork University Hospital

    Affiliation as printed

    Cork University Hospital

53. Nicholas Alexander Kennedy

    University of Limerick · Royal Devon University Healthcare NHS Foundation Trust

    Affiliation as printed

    Royal Devon University Healthcare NHS Foundation Trust

    and Health Research Institute, University of Limerick

54. Norelee Kennedy

    University of Limerick · Royal Devon University Healthcare NHS Foundation Trust

    Affiliation as printed

    Royal Devon University Healthcare NHS Foundation Trust

    and Health Research Institute, University of Limerick

55. Juha M. Kortelainen

    VTT Technical Research Centre of Finland

    Affiliation as printed

    VTT Technical Research Centre of Finland Ltd

56. Laura C M Kuijper Aachen

    Leiden University Medical Center

    Affiliation as printed

    Leiden University Medical Center

57. Samuel Labrecque

    Innsbruck Medical University

    Affiliation as printed

    Medical University of Innsbruck

58. Yasmin Laidler

    Newcastle upon Tyne Hospitals NHS Foundation Trust · Newcastle University

    Affiliation as printed

    Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK

    Newcastle University

59. Tanja Lange

    University Hospital Schleswig-Holstein · University of Lübeck

    Affiliation as printed

    University Hospital Schleswig-Holstein and University of Lübeck

60. Maria Boge Lauvsnes

    Stavanger University Hospital

    Affiliation as printed

    Stavanger University Hospital

61. Jimmy K. Limdi

    Manchester Academic Health Science Centre · Salford Royal NHS Foundation Trust · University of Manchester · Salford Royal Hospital

    Affiliation as printed

    Division of Musculoskeletal and Dermatological Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK

    Manchester Academic Health Science Centre

    Salford Royal Hospital

62. Ellen Lirani‐Silva

    Newcastle University

    Affiliation as printed

    Newcastle University

63. Victoria Macrae

    Newcastle upon Tyne Hospitals NHS Foundation Trust · Newcastle University

    Affiliation as printed

    Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK

    Newcastle University

64. Corina Maetzler

    Christian-Albrechts-Universität zu Kiel · University Hospital Schleswig-Holstein

    Affiliation as printed

    University Hospital Schleswig-Holstein and Kiel University

65. Mayca Marín
    Affiliation as printed

    Asociación Parkinson Madrid (APM), Madrid, Spain

66. Dario Masullo

    Johnson & Johnson (United States)

    Affiliation as printed

    Johnson & Johnson

67. Tania Nightingale

    Royal Devon University Healthcare NHS Foundation Trust

    Affiliation as printed

    Royal Devon University Healthcare NHS Foundation Trust

68. Alessandro Padovani

    Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · University of Brescia

    Affiliation as printed

    Brain Health Center, University of Brescia, Brescia, Italy

    Department of Continuity of Care and Frailty, ASST Spedali Civili Brescia Hospital, Brescia, Italy

    University of Brescia

69. Miles Parkes

    Cambridge University Hospitals NHS Foundation Trust

    Affiliation as printed

    Cambridge University Hospitals NHS Foundation Trust

70. Emma Paulides

    Erasmus MC

    Affiliation as printed

    Erasmus University Medical Centre

71. Clémence Pinaud
    Affiliation as printed

    Let It Care, Paris, France

72. Zaireen Pios

    St. Mark's Hospital · St Mark's Hospital

    Affiliation as printed

    St Marks Hospital

73. Costantino Pitzalis

    Queen Mary University of London · Barts Health NHS Trust · William Harvey Research Institute

    Affiliation as printed

    Barts NIHR BRC & NHS Trust, London, UK

    Queen Mary University of London, Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute

74. Alexandra Prodan

    empirica - Communication and Technology Research

    Affiliation as printed

    Empirica Gesellschaft für Kommunikations und Technologieforschung mbH, Bonn, Germany

75. Rana Zia Ur Rehman

    Johnson & Johnson (United Kingdom)

    Affiliation as printed

    Johnson & Johnson, Buckinghamshire, UK

76. Gabriela Riemekasten

    University Hospital Schleswig-Holstein · University of Lübeck

    Affiliation as printed

    University Hospital Schleswig-Holstein and University of Lübeck

77. Andrea Rizzardi

    Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · University of Brescia

    Affiliation as printed

    Department of Continuity of Care and Frailty, ASST Spedali Civili Brescia Hospital, Brescia, Italy

    University of Brescia

78. Matthew W. Roché

    CHDI Foundation

    Affiliation as printed

    CHDI Management/CHDI Foundation

79. Lynn Rochester

    NIHR Newcastle Biomedical Research Centre · Newcastle University

    Affiliation as printed

    National Institute for Health and Care Research (NIHR) Newcastle Biomedical Research Centre, Newcastle University, Newcastle upon Tyne, UK

    Newcastle University

80. Robbin Romijnders

    Christian-Albrechts-Universität zu Kiel · University Hospital Schleswig-Holstein

    Affiliation as printed

    University Hospital Schleswig-Holstein and Kiel University

81. Stefan Schreiber

    Christian-Albrechts-Universität zu Kiel · University Hospital Schleswig-Holstein

    Affiliation as printed

    University Hospital Schleswig-Holstein, Kiel University

82. Katarína Schwarzová

    Innsbruck Medical University

    Affiliation as printed

    Medical University of Innsbruck

83. Christian P. Selinger

    Leeds Teaching Hospitals NHS Trust

    Affiliation as printed

    Leeds Teaching Hospitals NHS Trust

84. Klaus Seppi

    Innsbruck Medical University

    Affiliation as printed

    Medical University of Innsbruck

85. Louise Stockley

    University of Cambridge · Cambridge University Hospitals NHS Foundation Trust

    Affiliation as printed

    Cambridge University Hospitals NHS Foundation Trust & University of Cambridge

86. Sreedhar Subramanian

    St. Mark's Hospital · St Mark's Hospital

    Affiliation as printed

    St Marks Hospital

87. Kai Sun

    Imperial College London

    Affiliation as printed

    Imperial College London

88. Nick Taptiklis

    Cambridge Cognition (United Kingdom)

    Affiliation as printed

    Cambridge Cognition

89. Gerlynn Tiongson

    St. Mark's Hospital · St Mark's Hospital

    Affiliation as printed

    St Marks Hospital

90. Kasper F. van der Zwaan Aachen

    Leiden University Medical Center

    Affiliation as printed

    Leiden University Medical Center

91. Evert-Ben van Veen
    Affiliation as printed

    MedLawconsult, Voorburg, The Netherlands

92. Louise Warren

    Queen Mary University of London · William Harvey Research Institute

    Affiliation as printed

    Queen Mary University of London, Centre for Experimental Medicine and Rheumatology, William Harvey Research Institute

93. D. Wenn

    iXscient

    Affiliation as printed

    iXscient Ltd, Twickenham, UK

94. Grzegorz Witkowski

    Wojskowy Instytut Medycyny Lotniczej

    Affiliation as printed

    Military Institute of Aviation Medicine

95. Alison Jane Yarnall

    NIHR Newcastle Biomedical Research Centre · Newcastle University

    Affiliation as printed

    National Institute for Health and Care Research (NIHR) Newcastle Biomedical Research Centre, Newcastle University, Newcastle upon Tyne, UK

    Newcastle University

96. Frederic Baribaud

    Bristol-Myers Squibb (United States)

    Affiliation as printed

    Bristol Meyers Squibb

97. Geert Van Gassen

    Takeda (Belgium)

    Affiliation as printed

    Medical Department, Takeda, Brussels, Belgium

98. Nikolay V. Manyakov

    Johnson & Johnson (United States)

    Affiliation as printed

    Johnson & Johnson

99. Wan-Fai Ng

    University College Cork · Newcastle upon Tyne Hospitals NHS Foundation Trust

    Affiliation as printed

    Department of Gastroenterology, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK

    HRB Clinical Research Facility Cork, University College Cork, Cork, Ireland