Bright Light Therapy as Possible Treatment Option for Fatigue in Multiple Sclerosis Patients - A Randomised Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- Medical University of Vienna
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change in fatigue levels
- Last Updated
- 5 years ago
Overview
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)
Investigators
Stefan Seidel
Associate Professor
Medical University of Vienna
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in fatigue levels
Time Frame: Day 15, Day 31
Improvement of MS-fatigue symptoms as measured with psychological testing (Testbatterie zur Aufmerksamkeitsprüfung; TAP)