Clinical trial NCT04681586: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Fatigue
Keywords: bright light therapy
MS-Fatigue
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: National Bank of Austria
First posted: 2020-12-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Change in fatigue levels
timeFrame: Day 1, Day 14, Day 30, Day 46
measure: Change in fatigue levels
timeFrame: Day 15, Day 31
Secondary outcomes:
Other outcomes:
measure: Change in nighttime sleep
timeFrame: Day 14, Day 30
measure: Change in daytime sleepiness
timeFrame: Day 15, Day 31
measure: Change in activity levels
timeFrame: Day 1 through day 46
measure: Change in psychological well-being
timeFrame: Day 1, Day 14, Day 30, Day 46
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References: