NCT06635928Completed
Bright Light Therapy in ME/CFS Patients
Assessing Fatigue and Attention in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Patients Before and After Treatment With Bright Light Therapy: a Prospective Randomized Controlled Crossover Study
Source: ClinicalTrials.gov · Last updated 10 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 36 (actual)
- First submitted
- 7 Oct 2024
- Start date
- 1 Jan 2021
- Primary completion date
- 25 Mar 2024
- Lead sponsor
- Medical University of Vienna
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06635928
What you commit to
- Study type: Interventional
- Participants enrolled: 36
- From 1 Jan 2021 to the primary completion date, 25 Mar 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with BLT (\> 10.000 lux) for a duration of \>2 weeks.
- Previously diagnosed medical conditions such as malignancies and hepatitis B or C virus infection.
- Medication use interacting with the circadian rhythm such as regular intake of sleeping pills, sleep-inducing antidepressant medication, and immunosuppressive medication.
- Change in regimen of ongoing treatment with antidepressants or stimulants within 4 weeks before study inclusion
Other illness
- Comorbidities explaining current fatigue symptoms such as sleep-wake disorders (narcolepsy, sleep apnea, periodic limb movements during sleep and irregular sleep-wake-rhythm), untreated hypothyroidism and iatrogenic conditions such as side effects of medication.
- Any past or current diagnosis of bipolar affective disorder; schizophrenia; dementias of any subtype; anorexia nervosa; or bulimia nervosa.
- Alcohol or other substance abuse disorders within 2 years before the onset of the chronic fatigue and at any time afterward.
- \>10 points in GAD-7 in the psychiatric screening process
Other
- Severe obesity as defined by a body mass index equal to or greater than 45.
- \>20 points in the HDRS-17
- Pregnancy
Who the study is looking for
- diagnosis of ME/CFS according to the IOM (IOM, 2015)
- Chalder Fatigue Score of ≥ 18 points (Likert scoring)
- age 18-60 years;
- ability to give informed consent.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.