IDEA-FAST COS
Research type
Research Study
Full title
Clinical observational study on the relationship between digital and clinical parameters of fatigue and sleep in neurodegenerative disorders and immune-mediated inflammatory diseases
IRAS ID
310624
Contact name
Wan-Fai Ng
Contact email
Sponsor organisation
University Hospital Schleswig-Holstein, Campus Kiel (UKSH)
Duration of Study in the UK
2 years, 5 months, 30 days
Research summary
The IDEA-FAST "Clinical Observational Study" is an observational study to investigate the relationship between digital and clinical parameters of fatigue, daytime sleepiness and sleep in neurodegenerative diseases and immune-mediated inflammatory diseases. These symptoms are prevalent in many diseases such as Parkinson's disease, Huntington's disease, inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus, and primary Sjögren's syndrome, and are perceived as very debilitating by patients and have growing personal, societal, and economic implications. While relatively little attention has been paid to the study of sleep and fatigue until recently, efforts are now being stepped up to curb the loss of mobility and energy and the resulting impairment of quality of life due to poor sleep quality, sleepiness, or fatigue. In order to develop effective treatments for sleep disturbances, daytime sleepiness, and fatigue, we need tools that can accurately and reliably detect and measure these symptoms. Existing measures of sleep and fatigue rely largely on self-report questionnaires that ask about the severity of symptoms "on average" or "at their worst" over a typical period of 1 to 4 weeks. Such questionnaires therefore lack sensitivity and reliability in capturing variations in symptoms. In addition, it is burdensome and resource-intensive for patients when such questionnaires must be presented repeatedly to patients, capture only a single time point per interview, and have variable capture periods. This study, which builds on the results of the pilot study, therefore explores a different approach that is accurate, reliable, simple, cost-effective, and can be used in real-world settings. It will more precisely determine the potential of mobile digital technologies (devices worn on or near the body) selected in the pilot study to objectively, accurately, reliably, and (semi)continuously measure and monitor sleep and fatigue compared to clinical testing and self-report. For this purpose, 2000 subjects will be recruited at up to 24 sites in Europe - 500 each with Parkinson's disease and inflammatory bowel disease, and 200 each with Huntington's disease, rheumatoid arthritis, systemic lupus erythematosus, primary Sjögren's syndrome, and 200 healthy subjects. These will be followed over an individual period of six months, during which two face-to-face visits and two videoconference visits ("remote visits") are scheduled. After each visit, subjects wear selected CE-certified devices and use cell phone apps for a period of one week each. Afterwards, a detailed self-report is collected on sleep, fatigue and various influencing parameters. The data collected will help to recommend reliable, accurate and less time-consuming digital parameters for fatigue and sleep for use in future clinical trials.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
22/SC/0080
Date of REC Opinion
8 Jun 2022
REC opinion
Further Information Favourable Opinion