Bright Light Therapy as Possible Treatment Option for MS-Fatigue

Study Overview
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Brief Summary
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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
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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)

Official Title
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Bright Light Therapy as Possible Treatment Option for Fatigue in Multiple Sclerosis Patients - A Randomised Controlled Trial

Conditions
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Multiple Sclerosis, Fatigue

Intervention / Treatment
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* Device: bright light therapy
* Device: dim red light


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bright white light<br> | Device: bright light therapy<br>* using a bright light therapy device (10.000 lux) for 30min every morning for two weeks<br>|
| Placebo Comparator: Dim red light<br> | Device: dim red light<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fatigue levels | Improvement of MS-fatigue symptoms as measured with questionnaires (Fatigue Severity Scale; FSS, Modified Fatigue Impact Scale; MFIS and a visual analogue scale) | Day 1, Day 14, Day 30, Day 46 | 
| Change in fatigue levels | Improvement of MS-fatigue symptoms as measured with psychological testing (Testbatterie zur Aufmerksamkeitsprüfung; TAP) | Day 15, Day 31 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MS-Fatigue, bright light therapy