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Bright Light Therapy as Possible Treatment Option for MS-Fatigue

Primary Purpose

Multiple Sclerosis, Fatigue

Status
Unknown status
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
bright light therapy
dim red light
Sponsored by
Medical University of Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring bright light therapy, MS-Fatigue

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Medical University of ViennaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bright white light

Dim red light

Arm Description

Outcomes

Primary Outcome Measures

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)
Change in fatigue levels
Improvement of MS-fatigue symptoms as measured with psychological testing (Testbatterie zur Aufmerksamkeitsprüfung; TAP)

Secondary Outcome Measures

Full Information

First Posted
October 20, 2020
Last Updated
December 19, 2020
Sponsor
Medical University of Vienna
Collaborators
National Bank of Austria
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1. Study Identification

Unique Protocol Identification Number
NCT04681586
Brief Title
Bright Light Therapy as Possible Treatment Option for MS-Fatigue
Official Title
Bright Light Therapy as Possible Treatment Option for Fatigue in Multiple Sclerosis Patients - A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
Collaborators
National Bank of Austria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Fatigue
Keywords
bright light therapy, MS-Fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bright white light
Arm Type
Experimental
Arm Title
Dim red light
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
bright light therapy
Intervention Description
using a bright light therapy device (10.000 lux) for 30min every morning for two weeks
Intervention Type
Device
Intervention Name(s)
dim red light
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in fatigue levels
Description
Improvement of MS-fatigue symptoms as measured with questionnaires (Fatigue Severity Scale; FSS, Modified Fatigue Impact Scale; MFIS and a visual analogue scale)
Time Frame
Day 1, Day 14, Day 30, Day 46
Title
Change in fatigue levels
Description
Improvement of MS-fatigue symptoms as measured with psychological testing (Testbatterie zur Aufmerksamkeitsprüfung; TAP)
Time Frame
Day 15, Day 31
Other Pre-specified Outcome Measures:
Title
Change in nighttime sleep
Description
Improvement in nighttime sleep as measured with polysomnography (PSG)
Time Frame
Day 14, Day 30
Title
Change in daytime sleepiness
Description
Improvement of sxcessive daytime sleepiness as measured using a multiple sleep latency test (MSLT) and Epworth Sleepiness Scale (ESS)
Time Frame
Day 15, Day 31
Title
Change in activity levels
Description
Rapprochement of activity levels according to circadian rhythms
Time Frame
Day 1 through day 46
Title
Change in psychological well-being
Description
Improvement in depression and anxiety scores as measured by Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI)
Time Frame
Day 1, Day 14, Day 30, Day 46

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefan Seidel, MD
Phone
0043 1 40 400 34280
Email
stefan.seidel@meduniwien.ac.at
First Name & Middle Initial & Last Name or Official Title & Degree
Lisa Voggenberger, MSc
Phone
0043 1 40 400 34280
Email
lisa.voggenberger@meduniwien.ac.at
Facility Information:
Facility Name
Medical University of Vienna
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefan Seidel, MD
Phone
0043 1 40 400 34280
Email
stefan.seidel@meduniwien.ac.at

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Bright Light Therapy as Possible Treatment Option for MS-Fatigue

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