Bright Light Therapy for Sleep Disorders in Multiple Sclerosis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Cognitive impairment, Ophthalmologic disorders, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

24 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you have been stable on your current MS therapy, antidepressants, and fatigue medication for a certain period before starting. If you meet these criteria, you won't need to stop taking your current medications.

What data supports the effectiveness of bright light therapy for sleep disorders in multiple sclerosis?

Research suggests that bright light therapy can help reduce fatigue in people with multiple sclerosis, which is often linked to sleep problems. While it hasn't been directly studied for sleep disorders in MS, its success in improving fatigue in other conditions indicates it might be beneficial. ^{1 2 3 4 5}

Is bright light therapy safe for humans?

Bright light therapy is considered a safe treatment option with little to no adverse events reported in studies for conditions like multiple sclerosis-related fatigue. ^{1 2 6 7 8}

How is bright light therapy different from other treatments for sleep disorders in multiple sclerosis?

Bright light therapy is unique because it is a non-drug treatment that uses exposure to bright light to help regulate sleep patterns, potentially improving sleep without the side effects associated with medications. It is also noted for being a cost-effective option with minimal adverse effects, making it a novel approach compared to traditional treatments for sleep disorders in multiple sclerosis. ^{1 2 9 10 11}

What is the purpose of this trial?

This trial tests if bright light therapy can safely and effectively reduce sleep disturbances in people with multiple sclerosis by helping reset their internal body clock. Bright light therapy has been explored for daytime sleepiness and insomnia in patients with Parkinson's disease and other conditions, showing potential benefits.

Research Team

Kathryn C Fitzgerald, ScD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for people with Multiple Sclerosis who have trouble sleeping. They should be stable on MS therapy or without it for 6 months, and if taking antidepressants or fatigue medication, stable for 3 months. Participants must not do shift work, have severe limb movement disorders, current depression, cognitive issues, certain eye diseases, recent time zone travel over two zones, a recent MS relapse or optic neuritis.

Inclusion Criteria

I have been on the same MS treatment or no treatment for at least 6 months.

I have trouble sleeping.

I have been on the same fatigue medication for at least 3 months.

Exclusion Criteria

I have had a recent MS flare-up or optic neuritis.

You have never been diagnosed with bipolar disorder before.

I have no other eye problems like cataracts, glaucoma, or blindness.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive bright light therapy for sleep disturbance, with sessions in the morning and afternoon/evening

2 weeks

Daily sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Light therapy

Trial Overview The study tests bright light therapy to see if it can help improve sleep in those with MS by possibly affecting certain cells in the retina that control our body clock and sleep patterns. It's a pilot study which means it's an early test of this idea before larger studies.

Participant Groups

Group I: Light therapy Experimental Treatment 1 Intervention

Participants receive one hour of morning (within 9:00am-11:00am) and afternoon/evening (within 5:00pm-7:00pm).

Light therapy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Light Therapy for:

• Seasonal Affective Disorder (SAD)
• Non-seasonal Major Depressive Disorder (MDD)

Approved in European Union as Phototherapy for:

• Seasonal Affective Disorder (SAD)
• Circadian Rhythm Disorders

Approved in Canada as Bright Light Therapy for:

• Seasonal Affective Disorder (SAD)
• Non-seasonal Major Depressive Disorder (MDD)

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

In a randomized sham-controlled trial involving 26 participants with multiple sclerosis, bright light therapy was evaluated for its effectiveness in reducing fatigue, but did not show a statistically significant difference compared to a dim red light sham intervention.

Despite the lack of significant results, participants generally experienced clinically relevant improvements in fatigue severity scores over the study period, suggesting that bright light therapy may still have potential benefits for managing MS-related fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bright light therapy as a non-pharmacological treatment option for multiple sclerosis-related fatigue: A randomized sham-controlled trial. Voggenberger, L., Böck, M., Moser, D., et al.[2022]

Bright white light therapy (BWLT) is safe and well-tolerated in individuals with multiple sclerosis (MS)-associated fatigue, with no serious adverse events leading to discontinuation during the 10-week study involving 41 participants.

Both BWLT and dim red light therapy (DRLT) resulted in significant reductions in fatigue severity scores, suggesting that the observed improvements may be influenced by a strong placebo effect, as there was no significant difference in efficacy between the two light therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light therapy for multiple sclerosis-associated fatigue: a randomized, controlled phase II trial. Mateen, FJ., Vogel, AC., Kaplan, TB., et al.[2021]

This study investigates the effectiveness of bright white light therapy in reducing fatigue among multiple sclerosis (MS) patients, who often find fatigue to be their most disabling symptom.

Participants will be randomized to receive either bright light (10,000 lux) or dim red light for 1 hour twice daily over a 4-week treatment period, with the primary outcome being the change in fatigue severity measured by the Fatigue Severity Scale (FSS).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light therapy for multiple sclerosis-associated fatigue: Study protocol for a randomized controlled trial. Mateen, FJ., Manalo, NC., Grundy, SJ., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Bright light therapy as a non-pharmacological treatment option for multiple sclerosis-related fatigue: A randomized sham-controlled trial. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

Light therapy for multiple sclerosis-associated fatigue: a randomized, controlled phase II trial. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

Sleep counts! Role and impact of sleep in the multimodal management of multiple sclerosis. [2023]

4. Netherlands pubmed.ncbi.nlm.nih.gov

The effects of aerobic exercise on sleep quality measures and sleep-related biomarkers in individuals with Multiple Sclerosis: A pilot randomised controlled trial. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Sleep in multiple sclerosis patients treated with interferon beta: an actigraphic study. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Ketogenic diet may improve sleep quality and daytime somnolence in patients affected by multiple sclerosis. Results of an exploratory study. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Light therapy for multiple sclerosis-associated fatigue: Study protocol for a randomized controlled trial. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Disease-modifying therapies do not affect sleep quality or daytime sleepiness in a large Australian MS cohort. [2023]

9. Denmark pubmed.ncbi.nlm.nih.gov

Clinical assessment and management of sleep disorders in multiple sclerosis: a literature review. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Sleep disorders in multiple sclerosis. [2015]

11. India pubmed.ncbi.nlm.nih.gov

Circadian rhythm sleep disorders in patients with multiple sclerosis and its association with fatigue: A case-control study. [2021]