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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 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).

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.

Find a Location

Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,039 Previous Clinical Trials
2,671,418 Total Patients Enrolled
18 Trials studying Multiple Sclerosis
1,784 Patients Enrolled for Multiple Sclerosis
Johns Hopkins UniversityLead Sponsor
2,317 Previous Clinical Trials
14,871,925 Total Patients Enrolled
30 Trials studying Multiple Sclerosis
2,544 Patients Enrolled for Multiple Sclerosis
National Institute on Minority Health and Health Disparities (NIMHD)NIH
427 Previous Clinical Trials
1,371,018 Total Patients Enrolled

Media Library

Light therapy (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04054050 — N/A
Multiple Sclerosis Research Study Groups: Light therapy
Multiple Sclerosis Clinical Trial 2023: Light therapy Highlights & Side Effects. Trial Name: NCT04054050 — N/A
Light therapy (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04054050 — N/A
~1 spots leftby Jan 2025