Bright Light Therapy in ME/CFS Patients

NCT06635928 | Completed

• 1 other identifier: MUVienna
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Keywords

bright light therapy; ME/CFS; attention testing; fatigue

Outcome Measures

Primary Outcomes (1)

• Chalder Fatigue Score

  subjective Fatigue score

  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

Secondary Outcomes (1)

• Test of Attentional Performance

  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

Study Arms (2)

Wait list

NO INTERVENTION

Intervention

EXPERIMENTAL

Bright light therapy for 2 weeks, 30min a day

Device: Bright light therapy

Interventions

Bright light therapy DEVICE

30min daily of 10.000 lux bright light therapy

Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• 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.
• Severe obesity as defined by a body mass index equal to or greater than 45.
• Medication use interacting with the circadian rhythm such as regular intake of sleeping pills, sleep-inducing antidepressant medication, and immunosuppressive medication.
• \>20 points in the HDRS-17
• \>10 points in GAD-7 in the psychiatric screening process
• Pregnancy

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (1)

• Ludwig B, Hauer L, Bock M, Schillerwein-Kral C, Weyer L, Moser D, Zehetmayer S, Trimmel K, Seidel S. Assessing fatigue in myalgic encephalomyelitis/chronic fatigue syndrome patients before and after treatment with bright light therapy: A prospective randomized controlled crossover study. Sleep Med. 2025 May;129:369-374. doi: 10.1016/j.sleep.2025.03.003. Epub 2025 Mar 14.

  PMID: 40120538 DERIVED

MeSH Terms

Conditions

Fatigue Syndrome, Chronic; Fatigue

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 10, 2024
• Study Start: January 1, 2021
• Primary Completion: March 25, 2024
• Study Completion: March 25, 2024
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)