Bright Light Therapy for Sleep Disturbance in People With Multiple Sclerosis

NCT ID: NCT04054050

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-22
• Study Completion Date: 2026-01-30

Brief Summary

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.

Detailed Description

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Light therapy

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

Group Type: EXPERIMENTAL

Light therapy

Intervention Type: OTHER

Bright light (10,000 lux) therapy will be administered via a light box.

Interventions

Light therapy

Bright light (10,000 lux) therapy will be administered via a light box.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Diagnosis of MS
• Evidence of sleep disturbance
• Stable on immunomodulatory MS therapy or no therapy for at least 6 months prior to study initiation
• Stable on antidepressants for at least 3 months prior to study initiation and no evidence
• Stable on fatigue medication for at least 3 months prior to study initiation
• Willing and able to provide informed consent and follow study procedures.

Exclusion Criteria

• Evidence of cognitive impairment
• Low risk for sleep disordered breathing
• Other comorbid ophthalmologic disorders (e.g. cataracts, glaucoma, blindness)
• Traveled across two time zones within 90 days of study screening.
• Not participating in shift work
• MS relapse or history of acute optic neuritis within 30 days
• No prior history of bipolar disorder
• No evidence of current depression
• Diagnosis of severe periodic limb movement disorder or severe restless legs syndrome

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kathryn C Fitzgerald, ScD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

R03HD101056

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00222887

Identifier Type: -

Identifier Source: org_study_id