Multiple SclerosisNCT04681586
Bright Light Therapy as Possible Treatment Option for MS-Fatigue
A study testing bright light therapy and dim red light in people with Multiple Sclerosis and Fatigue, run by Medical University of Vienna at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis, Fatigue
- What is being tested?
- bright light therapy and dim red light
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteAustria
- Study dates
- 1 Dec 2019to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Vienna
Vienna, 1090
Stefan Seidel, MD, 0043 1 40 400 34280, stefan.seidel@meduniwien.ac.at
About this study
Official title: Bright Light Therapy as Possible Treatment Option for Fatigue in Multiple Sclerosis Patients - A Randomised Controlled Trial
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.
Read the 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)
- Conditions
- Multiple Sclerosis, Fatigue
- Being tested
- bright light therapy, dim red light
- Keywords
- bright light therapy, MS-Fatigue
- Medical subject headings
- Multiple Sclerosis, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bright light therapyDevice
using a bright light therapy device (10.000 lux) for 30min every morning for two weeks
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
| Study group | Role | What they receive |
|---|---|---|
| Bright white light | Experimental | Not described Receives: Device: bright light therapy |
| Dim red light | Placebo comparator | Not described Receives: Device: dim red light |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: Day 15, Day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start1 Dec 2019
- Primary completionSep 2021 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- National Bank of Austria
- Responsible party
- Principal investigator, Stefan Seidel, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681586
- Sponsor's protocol ID
- AP18005ONB
- Status last verified
- Dec 2020
- First submitted
- 20 Oct 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bright Light Therapy as Possible Treatment Option for Fatigue in Multiple Sclerosis Patients - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04681586
- Acronym / sponsor ID
- AP18005ONB
- Conditions
- Multiple Sclerosis, Fatigue
- Keywords
- bright light therapy, MS-Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Collaborators
- National Bank of Austria
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright white light | Experimental | Device: bright light therapy |
| Dim red light | Placebo comparator | Device: dim red light |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bright light therapyusing a bright light therapy device (10.000 lux) for 30min every morning for two weeks | Device | Bright white light |
| dim red lightusing 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 | Device | Dim red light |
Primary outcome
Change in fatigue levels
Time frame: 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
Time frame: Day 15, Day 31
Improvement of MS-fatigue symptoms as measured with psychological testing (Testbatterie zur Aufmerksamkeitsprüfung; TAP)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bright light therapy and dim red light in people with Multiple Sclerosis and Fatigue, run by Medical University of Vienna at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Seidel, MD (0043 1 40 400 34280, stefan.seidel@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fatigue levels (time frame: Day 1, Day 14, Day 30, Day 46). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020; AzTrials last refreshed its copy on 6 Nov 2026.