Multiple Sclerosis, Fatigue
Conditions
Keywords
bright light therapy, MS-Fatigue
Brief summary
This study aims to investigate the effect of a 2-week trial of bright light therapy (BLT, 10.000 lx) on fatigue in multiple sclerosis (MS) patients. In this randomised placebo-controlled trial, the effect of bright light therapy will be compared to dim red light. MS-fatigue is quantified by patients using a visual analogue scale (VAS) and activity levels, subjective and objective sleep parameters and daytime sleepiness are measured.
Detailed description
Materials and methods: * visual analogue scale (4x/day for 6 weeks; measuring fatigue) * wrist actigraphy (6 weeks) * sleep diaries (6 weeks) * polysomnography (2x) * multiple sleep latency test (2x) * 4 subtests of the TAP (Testbatterie zur Aufmerksamkeitsprüfung; Alertness, Vigilance, Go/No-Go, Split Attention) * questionnaires (Fatigue Severity Scale, Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Beck Depression Inventory, Beck Anxiety Inventory, Modified Fatigue Impact Scale, Morningness-Eveningness Questionnaire)
Interventions
DEVICEbright light therapy
using a bright light therapy device (10.000 lux) for 30min every morning for two weeks
DEVICEdim red light
using the same device as the active group, but with an installed filter that dims light to \<300 lux for 30min every morning for two weeks
Sponsors
National Bank of Austria
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* MS patients who suffer from fatigue * Age between 18 and 65 years old * FSS Score of 36 or greater * ESS Score of 12 or greater * MEQ Score between 31 and 69 * BDI Score lower than 19 * BAI Score lower than 27 * EDSS lower than 4
Exclusion criteria
* sleep disorders (periodic limb movement disorders, obstructive or central sleep apnea, REM sleep behavior disorders) * change of antidepressive/fatigue influencing/sleep influencing/photosensizing/MS medication within the preceding 4 weeks * clinical MS-relapse within the preceding 4 weeks * consumption of alcohol: more than 1 glass per day * consumption of caffeine: more than 4 cups per day * current shift work * Jet lag (travelled across two or more time zones within 90 days before study screening * Retinopathy or other visual diseases/abnormalties * Traumatic brain injury within the preceding 5 years * pregnant or lactating * Participation in another clinical trial at the same time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fatigue levels | Day 1, Day 14, Day 30, Day 46 | Improvement of MS-fatigue symptoms as measured with questionnaires (Fatigue Severity Scale; FSS, Modified Fatigue Impact Scale; MFIS and a visual analogue scale) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in nighttime sleep | Day 14, Day 30 | Improvement in nighttime sleep as measured with polysomnography (PSG) |
| Change in daytime sleepiness | Day 15, Day 31 | Improvement of sxcessive daytime sleepiness as measured using a multiple sleep latency test (MSLT) and Epworth Sleepiness Scale (ESS) |
| Change in activity levels | Day 1 through day 46 | Rapprochement of activity levels according to circadian rhythms |
| Change in psychological well-being | Day 1, Day 14, Day 30, Day 46 | Improvement in depression and anxiety scores as measured by Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI) |
Countries
Austria
Contacts
Primary ContactStefan Seidel, MD
Backup ContactLisa Voggenberger, MSc
Outcome results
None listed