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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether bright light therapy can help people with multiple sclerosis (MS) sleep better. Sleep problems are common in people with MS and can complicate daily life. The study will determine if using light therapy (also known as phototherapy) twice a day improves sleep by affecting specific eye cells that regulate sleep patterns. Individuals diagnosed with MS and experiencing sleep disturbances might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to understanding how light therapy might enhance sleep for those with MS.

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 prior data suggests that bright light therapy is safe for people with multiple sclerosis?

Research has shown that bright light therapy is generally safe and easy to use. A review of studies found that this treatment carries low risks. Some studies mention mild side effects, such as eye irritation, but these are usually minor and temporary. Overall, evidence suggests that bright light therapy is a safe option for managing sleep problems, even for people with multiple sclerosis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Bright light therapy is unique because it offers a non-drug approach to managing sleep disorders in people with multiple sclerosis (MS). Unlike traditional treatments that often rely on medications like melatonin or sleep aids, bright light therapy involves exposure to specific light wavelengths at scheduled times to help regulate the body's internal clock. Researchers are excited because this method could provide a natural alternative with fewer side effects, potentially improving sleep quality and overall well-being for those with MS.

What evidence suggests that light therapy might be an effective treatment for sleep disorders in MS?

Research shows that bright light therapy, which participants in this trial will receive, might help people with multiple sclerosis (MS) sleep better. Studies indicate it can improve both sleep quality and duration. This therapy influences specific eye cells that regulate sleep and body clocks. Although not all studies focus on MS, similar sleep benefits have appeared in other conditions. Overall, evidence suggests that bright light therapy could be a promising way to manage sleep problems in MS patients. ^{2 6 7 8 9}

Who Is on the Research Team?

Kathryn C Fitzgerald, ScD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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.

Willing and able to provide informed consent and follow study procedures.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04054050

Bright Light Therapy for Sleep Disturbance in People With ... People with MS are a markedly high risk for sleep disturbance. Estimates of the lifetime prevalence of sleep disturbance in MS reach 50%; sleep disturbance is ...

2. grantome.com grantome.com/grant/NIH/R03-HD101056-01

Bright Light Therapy for Sleep Disturbance in Multiple ... ... effective for reducing sleep disturbance (specifically, reducing insomnia, fatigue and improving sleep efficiency, quantity and quality as secondary outcomes).

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04054050?term=phototherapy&cond=multiple%20sclerosis&viewType=Table&rank=2

Study Details | Bright Light Therapy for Sleep Disturbance ... Data collected at the beginning of a clinical study for all participants and for each arm or comparison group. These data include demographics, such as age, sex ...

4. withpower.com withpower.com/trial/phase-parasomnias-1-2021-ed115

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 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10699648/

The effect of light therapy on sleep disorders and ... Light therapy leads to significant improvement in sleep and psychobehavioral symptoms and is associated with relatively fewer side effects in patients with AD.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6392596/

Light therapy for multiple sclerosis-associated fatigue We present a study design and rationale for randomizing a nonpharmacological intervention for MS-associated fatigue, using bright light therapy.

7. neurologylive.com neurologylive.com/view/innovative-trial-test-effect-light-therapy-progressive-ms-related-fatigue

Innovative Trial to Test Effect of Light Therapy on ... NO-FATIGUE study explores light therapy's safety and biomarkers to alleviate fatigue in progressive MS by synchronizing circadian rhythms. The ...

8. trialx.com trialx.com/clinical-trials/listings/288867/study-of-circadian-focused-light-therapy-in-progressive-multiple-sclerosis/

Study of Circadian Focused Light Therapy in Progressive ... The risks of this study include the possibility of eye irritation during the light therapy, and loss of confidentiality. The primary outcome ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0885392425005901

Effectiveness and Safety of Bright Light Therapy in ... Bright light therapy is considered a well-tolerated and easy to administer form of treatment with relatively low costs. Our systematic review is focused on the ...