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Bright Light Therapy as Possible Treatment Option for MS-Fatigue

NCT ID: NCT04681586

Last Updated: 2020-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2022-01-31

Brief Summary

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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

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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)

Conditions

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Multiple Sclerosis Fatigue

Keywords

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bright light therapy MS-Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Bright white light

Group Type EXPERIMENTAL

bright light therapy

Intervention Type DEVICE

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

Dim red light

Group Type PLACEBO_COMPARATOR

dim red light

Intervention Type DEVICE

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

Interventions

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bright light therapy

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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Bank of Austria

OTHER_GOV

Sponsor Role collaborator

Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Stefan Seidel

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Medical University of Vienna

Vienna, , Austria

Site Status RECRUITING

Countries

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Austria

Central Contacts

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Stefan Seidel, MD

Role: CONTACT

Phone: 0043 1 40 400 34280

Email: [email protected]

Lisa Voggenberger, MSc

Role: CONTACT

Phone: 0043 1 40 400 34280

Email: [email protected]

Facility Contacts

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Stefan Seidel, MD

Role: primary

Other Identifiers

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AP18005ONB

Identifier Type: -

Identifier Source: org_study_id