Bright light therapy in rheumatoid arthritis to improve symptoms of fatigue and other disease outcomes.
- Conditions
- Rheumatoid arthritis
- Registration Number
- NL-OMON22327
- Lead Sponsor
- eiden University
- Brief Summary
A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 48
Eligible patients are Dutch-speaking patients from the Department of Rheumatology of the Leiden University Medical Center with a physician-based diagnosis of RA and an age ≥ 18y.
A subject must meet all of the following criteria:
I.Treatment with glucocorticoids, melatonin, or photosensitizing medication and/or changed in type or dose within the last 3 months before start of the study.
II.Patient's medical conditions or recent medical events potentially compromises the effects of safety of light therapy (e.g. psychosis, mania, (probable) dementia, severe drug or alcohol abuse, delirium, severe acute suicidality, history of light-induced migraine or epilepsy or severe side effects to light therapy in the past, and/or pre-existing ocular abnormalities (e.g. glaucoma, retinitis, retinopathy, and/or macular degeneration)).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main endpoint is the difference between the intervention and control group in change from T0 to T1 in the primary study outcome fatigue (CIS-8 score). This difference will be reported as descriptive and will be preliminary statistically tested.
- Secondary Outcome Measures
Name Time Method The secondary outcomes (e.g. disease activity (Disease Activity Scale (DAS)) and circadian entrainment (assessed by the melatonin onset in saliva and a sleep diary)) will be explored in the same way as the primary outcome. We also report the relevant parameter estimates and variances needed to design a possible future full-scale RCT.