Bright Light Therapy as Possible Treatment Option for MS-Fatigue

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04681586
• Other study ID #: AP18005ONB
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: January 2022

Study information

• Verified date: December 2020
• Source: Medical University of Vienna
• Contact: Stefan Seidel, MD
• Phone: 0043 1 40 400 34280
• Email: stefan.seidel[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: January 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatigue
• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Vienna	National Bank of Austria

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in nighttime sleep	Improvement in nighttime sleep as measured with polysomnography (PSG)	Day 14, Day 30
Other	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
Other	Change in activity levels	Rapprochement of activity levels according to circadian rhythms	Day 1 through day 46
Other	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
Primary	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
Primary	Change in fatigue levels	Improvement of MS-fatigue symptoms as measured with psychological testing (Testbatterie zur Aufmerksamkeitsprüfung; TAP)	Day 15, Day 31