An interventional study of Bright light therapy in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-10-10.
Sponsored by Medical University of Vienna · Not applicable, Interventional, and Treatment
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In this study patients with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) will receive bright light therapy through portable lamps for 2 weeks. They will either start with this treatment and then go through a wash-out period of two weeks followed by a wait period of two weeks or they will start with the wait period, followed by a wash-out period, followed by the treatment phase. Patients are asked to fill out questionnaires (rating their level of fatigue) and they go through a standardized computer test assessing their attention levels, both at multiple times throughout the study. The aim of this study is to find out if treatment with bright light will improve subjective fatigue levels and objective attention levels inME/CFS patients.
Chronic Fatigue Syndrome (CFS), also referred to as Myalgic Encephalomyelitis (ME), is a chronic, debilitating condition of unknown etiology. Bright light therapy (BLT) has shown promising results in studies investigating its effect in patients with neurological disorders experiencing fatigue symptoms (Mateen et al., 2020, Sinclair et al., 2014, West et al., 2019). Since effective and low to no side effect therapies are duly needed for the treatment of ME/CFS, we propose a randomized-controlled treatment approach with bright light therapy (BLT).
In this proposed study, a total of 38 out-patients with a diagnosis of ME/CFS according to the criteria of the Institute of Medicine will be randomly assigned to a crossover design starting out either with BLT or being waitlisted for the course of two weeks. Portable light boxes emitting full-spectrum visible light with a luminance intensity of 10,000 lux measured at a distance of 50 cm will be used at the participants' home for 2 weeks.
Primary outcome of the study will be the level of fatigue before and after treatment as operationalized by the Chalder Fatigue Score. Secondary outcomes include the objective activity pattern as measured by actigraphy as well as cognitive and metacognitive functioning assessed before and after treatment.
264 studies on the registry are indexed under Fatigue Syndrome, Chronic; 62 are open to participants now.
This study's enrollment of 36 is below the median of 60 across 178 interventional studies indexed under Fatigue Syndrome, Chronic.
Browse Fatigue Syndrome, Chronic studies →Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.
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Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
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Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bright light therapy for 2 weeks, 30min a day
Device: Bright light therapy
30min daily of 10.000 lux bright light therapy
Chalder Fatigue Score
subjective Fatigue score
Time frame: As a baseline variable: day 1 of inclusion in the study, day 7 before treatment/wait list, day 21 after treatment/wait list, day 35 before treatment/wait list and day 42 after treatment/wait list
Test of Attentional Performance
three subtests of attention
Time frame: On day 7 before treatment/wait list, day 21 after treatment/wait list, day 35 before treatment/wait list and day 42 after treatment/wait list
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2021 to primary completion in Mar 2024, 38 months.
Of 73 non-industry interventional studies with no phase under Fatigue Syndrome, Chronic, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 38 months is above that.
Counting every sponsor, half of 78 studies reached it within 23 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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