Bright Light Therapy as Possible Treatment Option for MS-Fatigue

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

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.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis; Fatigue
• Intervention / Treatment: Device: bright light therapy; Device: dim red light

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 Type: Interventional
• Enrollment (Anticipated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stefan Seidel, MD; Phone Number: 0043 1 40 400 34280; Email: stefan.seidel@meduniwien.ac.at
• Study Contact Backup: Name: Lisa Voggenberger, MSc; Phone Number: 0043 1 40 400 34280; Email: lisa.voggenberger@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University of Vienna
    • Contact: Stefan Seidel, MD; Phone Number: 0043 1 40 400 34280; Email: stefan.seidel@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in nighttime sleep	Improvement in nighttime sleep as measured with polysomnography (PSG)	Day 14, Day 30
Change in daytime sleepiness	Improvement of sxcessive daytime sleepiness as measured using a multiple sleep latency test (MSLT) and Epworth Sleepiness Scale (ESS)	Day 15, Day 31
Change in activity levels	Rapprochement of activity levels according to circadian rhythms	Day 1 through day 46
Change in psychological well-being	Improvement in depression and anxiety scores as measured by Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI)	Day 1, Day 14, Day 30, Day 46

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: National Bank of Austria

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: December 19, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Actual): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 19, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: bright light therapy; MS-Fatigue
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Fatigue
• Other Study ID Numbers: AP18005ONB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No