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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
Stable on immunomodulatory MS therapy or no therapy for at least 6 months prior to study initiation
Evidence of sleep disturbance
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights

Study Summary

This trial will test whether bright light therapy can reduce sleep disturbance in people with MS, and whether it improves function of cells that help regulate sleep.

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.Check my eligibility
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.See study design
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 on the same MS treatment or no treatment for at least 6 months.
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I have trouble sleeping.
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I have been on the same fatigue medication for at least 3 months.
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I have been on the same antidepressants for over 3 months with no issues.
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I have been diagnosed with multiple sclerosis (MS).

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of adverse events
Secondary outcome measures
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

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).

Find a Location

Who is running the clinical trial?

National Institute on Minority Health and Health Disparities (NIMHD)NIH
373 Previous Clinical Trials
1,214,432 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,242 Previous Clinical Trials
14,816,613 Total Patients Enrolled
30 Trials studying Multiple Sclerosis
2,613 Patients Enrolled for Multiple Sclerosis
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,952 Previous Clinical Trials
2,660,820 Total Patients Enrolled
18 Trials studying Multiple Sclerosis
1,734 Patients Enrolled for Multiple Sclerosis

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this experiment actively enrolling participants?

"The information on clinicaltrials.gov shows that this trial is no longer enrolling candidates. The study was initially put up on February 22nd 2021 and the last update came a few months ago, May 2nd 2022. While it may not be available anymore, 683 other trials are actively looking for participants currently."

Answered by AI
~5 spots leftby Jan 2025