Bright Light Therapy as Possible Treatment Option for MS-Fatigue

Not Applicable

• Conditions: Fatigue; Multiple Sclerosis
• Interventions: Device: bright light therapy; Device: dim red light

• Registration Number: NCT04681586
• Lead Sponsor: Medical University of Vienna

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)

Study Timeline

• Study Start: 2019-12-01
• Study First Submitted: 2020-10-20
• Status Verified: 2020-12
• Study First Submitted QC: 2020-12-19
• Last Update Submitted: 2020-12-19
• Study First Posted: 2020-12-23
• Last Update Posted: 2020-12-23
• Primary Completion: 2021-09
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bright white light	bright light therapy	-
Dim red light	dim red light	-

Primary Outcome Measures

Name	Time	Method
Change in fatigue levels	Day 15, Day 31	Improvement of MS-fatigue symptoms as measured with psychological testing (Testbatterie zur Aufmerksamkeitsprüfung; TAP)

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria