Objective assessment tools for measuring fatigue in clinical studies
Research type
Research Study
Full title
Develop objective assessment tools for measuring fatigue in clinical studies
IRAS ID
247550
Contact name
Wan-Fai Ng
Contact email
Sponsor organisation
The Newcastle upon Tyne NHS Foundation trust
Clinicaltrials.gov Identifier
8775, R&D number
Duration of Study in the UK
1 years, 6 months, 26 days
Research summary
Fatigue is a prominent symptom in older people and in many chronic conditions such as primary Sjogren’s syndrome (pSS). The causes of fatigue are unclear and we have no effective treatment at present. Fatigue severity often vary making it difficult to measure using simple questionnaires which rely on recollection of the symptoms. The lack of accurate and reliable measurement of fatigue is a major barrier to fatigue research and developing new treatments for fatigue.
Based on the descriptions from fatigued patients of their symptom and how fatigue impacts their lives, we believe that using digital devices to capture physical activities and other physiological parameters can give us an indirect but objective assessment of fatigue severity as well as the impact on their daily livings. These devices are called “biosensors”. Additionally, patients with fatigue often report that their concentrations are affected, their reaction time has slowed, they become forgetful and find it difficult to remember things. These symptoms can be measured objectively using simple tests which we call “neurocognitive function tests”.
This pilot study aims to explore the use of biosensors and neuropsychological tests as tools to objectively measure fatigue. More specifically, we will study 120 patients with pSS (60 with fatigue and 60 without). During the study, participants will wear two medically certified biosenses to capture data on physical activity, sleep and other physiological measures. They will also be asked to complete several neuropsychological tests. In addition, we will collect data that might influence the results of the study such as pain and depression. For each participant, we will collect data over two separate 7-day periods 6-8 weeks apart. We will use standard statistics techniques as well as more advanced modelling methods and artificial intelligence to find identify what data collected by these biosensors and neuropsychological tests we can use to measure fatigue. The data will then be used to prepare funding applications for a larger study to confirm the results.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
19/NE/0002
Date of REC Opinion
1 Feb 2019
REC opinion
Further Information Favourable Opinion