Bright Light Therapy as Possible Treatment Option for MS-Fatigue

Medical University of Vienna36 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Multiple Sclerosis Fatigue

Interventions

bright light therapyDEVICE

using a bright light therapy device (10.000 lux) for 30min every morning for two weeks

dim red lightDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Medical University of Vienna

Vienna, Austria

RECRUITING

Outcomes

Primary Outcomes

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)

Time frame: 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)

Time frame: Day 15, Day 31

Central Contacts

Stefan Seidel, MD

CONTACT

0043 1 40 400 34280 stefan.seidel@meduniwien.ac.at

Lisa Voggenberger, MSc

CONTACT

0043 1 40 400 34280 lisa.voggenberger@meduniwien.ac.at

Data from ClinicalTrials.gov

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