What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include disease-modifying therapies such as fingolimod, interferon beta-1a, and clemastine fumarate. Fingolimod is associated with side effects like headache, elevated liver enzymes, diarrhea, and increased risk of infections. Interferon beta-1a can cause flu-like symptoms, injection site reactions, and liver abnormalities. Clemastine fumarate, studied for its remyelinating properties, has been linked to fatigue but no serious adverse events. Bright Light Therapy, which is being studied for its potential to reduce sleep disturbances in MS by regulating circadian rhythms, generally has fewer side effects, primarily related to eye strain or discomfort from light exposure.

What prior FDA approvals exist?

The FDA has approved several treatments for Multiple Sclerosis (MS), primarily focusing on disease-modifying therapies (DMTs) that aim to reduce the frequency and severity of relapses and slow disease progression. These include interferon beta medications (e.g., Avonex, Betaseron), glatiramer acetate (Copaxone), and newer oral medications like fingolimod (Gilenya), dimethyl fumarate (Tecfidera), and siponimod (Mayzent). While these treatments do not specifically target circadian rhythm regulation via retinal ganglion cells, they represent the broader landscape of MS management. Bright Light Therapy, which is being studied for its potential to improve sleep disturbances in MS by regulating circadian rhythms, represents an innovative approach that differs from traditional pharmacological treatments.

What other types of research exist?

Promising alternatives to Bright Light Therapy for MS patients include: 1) Melatonin supplementation, which can help regulate sleep-wake cycles by mimicking the body's natural hormone. 2) Chronotherapy, which involves gradually adjusting sleep times to reset the circadian clock. 3) Blue light-blocking glasses, which can reduce evening light exposure and help advance sleep phases. 4) Cognitive Behavioral Therapy for Insomnia (CBT-I), which addresses behavioral and psychological factors affecting sleep. These alternatives are supported by research and clinical practice guidelines for circadian rhythm disorders.

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Bright Light Therapy for Sleep Disorders in Multiple Sclerosis

N/A

Waitlist Available

Led By Kathryn C Fitzgerald, ScD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of MS

Be older than 18 years old

Must not have

Other comorbid ophthalmologic disorders (e.g. cataracts, glaucoma, blindness)

Diagnosis of severe periodic limb movement disorder or severe restless legs syndrome

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Bright light therapy is generally safe but may cause eyestrain, headache, nausea or agitation in some individuals. People might also experience changes in their sleep patterns when they start the treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with multiple sclerosis (MS).

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have been diagnosed with severe restless legs syndrome or severe periodic limb movement.

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I am not currently experiencing depression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of adverse events

Secondary study objectives

Change in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS)

Change in fatigue severity as assessed by the Neuro-QoL fatigue questionnaire

Change in function of intrinsically photosensitive retinal ganglion cells

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Light therapyExperimental Treatment1 Intervention

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

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Bright light therapy, being studied for its potential benefits in MS, works by stimulating retinal ganglion cells that regulate circadian rhythms and sleep. This is particularly important for MS patients as sleep disturbances are common and can significantly impact their quality of life. By improving sleep patterns, bright light therapy may help alleviate some of the fatigue and cognitive issues associated with MS. Other common treatments for MS include disease-modifying therapies (DMTs) like interferons and monoclonal antibodies, which work by modulating the immune system to reduce inflammation and slow disease progression. These treatments are crucial for managing the chronic and progressive nature of MS, aiming to reduce relapses and delay disability.