NCT04681586

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for not_applicable multiple-sclerosis

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

December 23, 2020

Status Verified

December 1, 2020

Enrollment Period

1.8 years

First QC Date

October 20, 2020

Last Update Submit

December 19, 2020

Conditions

Multiple SclerosisFatigue

Keywords

bright light therapyMS-Fatigue

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Change in nighttime sleep

    Day 14, Day 30

  • Change in daytime sleepiness

    Day 15, Day 31

  • Change in activity levels

    Day 1 through day 46

  • +1 more other outcomes

Study Arms (2)

Bright white light

EXPERIMENTAL
Device: bright light therapy

Dim red light

PLACEBO COMPARATOR
Device: dim red light

Interventions

bright light therapyDEVICE

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

Bright white light
dim red lightDEVICE

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

Dim red light

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Multiple SclerosisFatigue

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhototherapyTherapeutics

Central Study Contacts

Stefan Seidel, MD

CONTACT

0043 1 40 400 34280stefan.seidel@meduniwien.ac.at

Lisa Voggenberger, MSc

CONTACT

0043 1 40 400 34280lisa.voggenberger@meduniwien.ac.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 20, 2020

First Posted

December 23, 2020

Study Start

December 1, 2019

Primary Completion

September 1, 2021

Study Completion

January 1, 2022

Last Updated

December 23, 2020

Record last verified: 2020-12

Locations

AU(1)