An interventional study of Light therapy in Multiple Sclerosis, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Treatment
Sleep disturbance is common in people with multiple sclerosis (MS) and contributes to diminished quality of life. Bright light therapy may be an innovative strategy to reduce sleep disturbance in MS, possibly through its effects on a subtype of retinal ganglion cells that help regulate circadian rhythms and sleep. This pilot study will evaluate whether, in people with MS, bright light therapy reduces sleep disturbance and explore whether light therapy improves function of these cells.
Multiple sclerosis (MS), an inflammatory and neurodegenerative disorder of the central nervous system (CNS), is the most common cause of progressive neurologic dysfunction in early to middle adulthood. 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 also associated with excess MS-associated morbidity and diminished quality of life. Despite the high burden of impaired sleep and its contribution to adverse MS outcomes, effective approaches to treat and ameliorate disturbed sleep in people with MS remain poorly understood. There is unmet need to develop safe and effective rehabilitative alternatives to mitigate sleep disturbance in MS. Prior research supports the use of timed bright light therapy (LT) as one such approach for insomnia and sleepiness in those with sleep disorders or other neurologic diseases. Yet, the safety and potential effectiveness of timed LT have yet to be tested in MS. The goal of the proposed study is to conduct a detailed intervention study testing if timed bright LT in people with MS is 1) safe (primary outcome) and 2) potentially effective for reducing sleep disturbance (specifically, reducing insomnia, fatigue and improving sleep efficiency, quantity and quality as secondary outcomes). The study will also explore whether LT stimulates a novel subtype of retinal ganglion cells which are central to the regulation of circadian rhythms and sleep.
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 27 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
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Exclusion Criteria:
Participants receive one hour of morning (within 9:00am-11:00am) and afternoon/evening (within 5:00pm-7:00pm).
Other: Light therapy
Bright light (10,000 lux) therapy will be administered via a light box.
Number of adverse events
The number of adverse events will be documented and categorized by organ system
Time frame: 2 weeks
Change in sleep quantity as assessed by the Pittsburgh Sleep Quality Index (PSQI)
The PSQI has a sub-component that quantifies sleep quantity. The investigators will assess change in sleep quantity (difference in minutes) as assessed by this sub-component.
Time frame: Baseline, 2 weeks
Change in sleep efficiency as assessed by the Pittsburgh Sleep Quality Index (PSQI)
The PSQI has a sub-component that quantifies sleep efficiency. The investigators will assess change in sleep efficiency (difference in minutes) as assessed by this sub-component.
Time frame: Baseline, 2 weeks
Change in overall sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
The PSQI has an overall score that ranges from 0 to 21. The investigators will assess change in the overall PSQI score.
Time frame: Baseline, 2 weeks
Change in insomnia severity as assessed by the Insomnia Severity Index (ISI)
The ISI is validated questionnaire assessing insomnia from which a total score is calculated and ranges from 0 to 28. The investigators will calculate change in the overall ISI score.
Time frame: Baseline, 2 weeks
Change in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS)
The ESS is validated questionnaire assessing daytime sleepiness from which a total score is calculated and ranges from 0 to 24. The investigators will calculate change in the overall ESS score.
Time frame: Baseline, 2 weeks
Change in fatigue severity as assessed by the Neuro-QoL fatigue questionnaire
The Neuro-QoL fatigue severity score (short form) is a validated 8-question assessment of fatigue from which T-scores ranging from 0 to 100 can be obtained. The investigators will assess change in Neuro-QoL fatigue severity.
Time frame: Baseline, 2 weeks
Plan to share: No — Individual participant data will not be available to other researchers. Since the study will enroll only 24 individuals, even if stripped of identifiers, it may still be possible to identify participants. Thus, data will not be shared.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Johns Hopkins University