Identifying digital measures for the assessment of sleep and fatigue
Research type
Research Study
Full title
Identifying candidate digital measures for the assessment of sleep and fatigue in the home environment
IRAS ID
282329
Contact name
Victoria Macrae
Contact email
Sponsor organisation
The Newcastle upon Tyne Hospitals Trust
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Sleep disturbances and fatigue have a large impact on physical, mental and social well-being. These symptoms are highly prevalent in many diseases including Rheumatoid Arthritis (RA), Primary Sjögren’s Syndrome (PSS) and Systemic Lupus Erythematosus (SLE). Current assessments of sleep and fatigue and their impact on health-related quality of life (HRQoL) and activities of daily living (ADL) rely on patient reported outcome measures (PROMs). However, PROMs are prone to recall bias, reliability issues and poor sensitivity to change.
The lack of effective assessment tools for sleep and fatigue is a key barrier to therapeutic development and clinical management of these symptoms. A novel approach is needed that is accurate and can be used in the natural environment of the patients. Mobile digital technologies (devices worn on or near the body) have the potential for measuring and monitoring sleep, fatigue and other functional outcomes relevant for daily living objectively and reliably.
The aim of this feasibility study is to identify candidate digital measurements (or combinations of measurements) that are related to fatigue, sleep disturbances and disabilities in specific ADL. Participants (healthy volunteers, patients with RA, SLE or PSS) will attend the Newcastle upon Tyne Hospitals Trust at the start of the study during which their disease (for patient participants) and their symptoms, HRQoL and ADLs will be assessed using standardised measurement tools. Participants have an option to donate blood, urine, and/or stool sample for biobanking for future research. Participants will then use different digital technologies (in various combinations in order to capture different digital measurements) over a 42-day period (including breaks), during which simple symptom diary will be collected. Participants will also attend an optional end of study visit to provide feedback on their experience of the study. The most promising digital parameters identified will be further evaluated in a subsequent study.
REC name
London - Riverside Research Ethics Committee
REC reference
20/PR/0185
Date of REC Opinion
6 Aug 2020
REC opinion
Favourable Opinion