Bright Light Therapy for Sleep Disturbance in People With Multiple Sclerosis

NCT04054050 | Completed DMC

• 2 other identifiers: IRB00222887R03HD101056
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

sleep disturbance; insomnia; fatigue

Outcome Measures

Primary Outcomes (1)

• Number of adverse events

  The number of adverse events will be documented and categorized by organ system

  2 weeks

Secondary Outcomes (9)

• Change in sleep quantity as assessed by the Pittsburgh Sleep Quality Index (PSQI)

  Baseline, 2 weeks

• Change in sleep efficiency as assessed by the Pittsburgh Sleep Quality Index (PSQI)

  Baseline, 2 weeks

• Change in overall sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)

  Baseline, 2 weeks

• Change in sleep efficiency as assessed by actigraphy

  Baseline, 2 weeks

• Change in total sleep time

  Baseline, 2 weeks

Study Arms (1)

Light therapy

EXPERIMENTAL

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

Other: Light therapy

Interventions

Light therapy OTHER

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

Light therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Johns Hopkins University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Parasomnias; Sleep Initiation and Maintenance Disorders; Fatigue

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Sleep Wake Disorders; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Kathryn C Fitzgerald, ScD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2019
• First Posted: August 13, 2019
• Study Start: February 22, 2021
• Primary Completion: July 30, 2025
• Study Completion: January 30, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)