Bright Light Therapy as Possible Treatment Option for MS-Fatigue

Sponsor

Medical University of Vienna (Other)

Overall Status

Recruiting

CT.gov ID

NCT04681586

Collaborator

National Bank of Austria (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis Fatigue	Device: bright light therapy Device: dim red light	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2019

Anticipated Primary Completion Date :

Sep 1, 2021

Anticipated Study Completion Date :

Jan 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in fatigue levels [Day 1, Day 14, Day 30, Day 46]
Improvement of MS-fatigue symptoms as measured with questionnaires (Fatigue Severity Scale; FSS, Modified Fatigue Impact Scale; MFIS and a visual analogue scale)
Change in fatigue levels [Day 15, Day 31]
Improvement of MS-fatigue symptoms as measured with psychological testing (Testbatterie zur Aufmerksamkeitsprüfung; TAP)

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of Vienna	Vienna		Austria	1090

Sponsors and Collaborators

Medical University of Vienna
National Bank of Austria

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Stefan Seidel, Associate Professor, Medical University of Vienna

ClinicalTrials.gov Identifier:

NCT04681586

Other Study ID Numbers:

AP18005ONB

First Posted:

Dec 23, 2020

Last Update Posted:

Dec 23, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Stefan Seidel, Associate Professor, Medical University of Vienna

bright light therapy

MS-Fatigue

Additional relevant MeSH terms:

Multiple Sclerosis

Sclerosis

Fatigue

Study Results

No Results Posted as of Dec 23, 2020