Bright Light Therapy as Possible Treatment Option for MS-Fatigue

Medical University of Vienna

Status: Unknown

Conditions: Multiple Sclerosis; Fatigue

Treatments: Device: dim red light; Device: bright light therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04681586

AP18005ONB

Details and patient eligibility

About

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.

Full 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)

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups, including a placebo group

Bright white light

Experimental group

Treatment:

Device: bright light therapy

Dim red light

Placebo Comparator group

Treatment:

Device: dim red light