Multiple SclerosisNCT04054050
Bright Light Therapy for Sleep Disturbance in People With Multiple Sclerosis
A study testing Light therapy in people with Multiple Sclerosis, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Light therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Feb 2021to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- No prior history of bipolar disorder
- No evidence of current depression
- Diagnosis of severe periodic limb movement disorder or severe restless legs syndrome
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
About this study
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.
Read the 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
- Being tested
- Light therapy
- Keywords
- sleep disturbance, insomnia, fatigue
- Medical subject headings
- Multiple Sclerosis, Parasomnias, Sleep Initiation and Maintenance Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Light therapyOther
Bright light (10,000 lux) therapy will be administered via a light box.
| Study group | Role | What they receive |
|---|---|---|
| Light therapy | Experimental | Participants receive one hour of morning (within 9:00am-11:00am) and afternoon/evening (within 5:00pm-7:00pm). Receives: Other: Light therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
The number of adverse events will be documented and categorized by organ system
Measured: 2 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start22 Feb 2021
- Primary completion30 Dec 2025
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Kathryn C Fitzgerald, ScD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054050
- Sponsor's protocol ID
- IRB00222887
- Other IDs
- R03HD101056
- Status last verified
- Oct 2026
- First submitted
- 9 Aug 2019
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bright Light Therapy for Sleep Disturbance in People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04054050
- Acronym / sponsor ID
- IRB00222887
- Conditions
- Multiple Sclerosis
- Keywords
- sleep disturbance, insomnia, fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Light therapy | Experimental | Other: Light therapyParticipants receive one hour of morning (within 9:00am-11:00am) and afternoon/evening (within 5:00pm-7:00pm). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Light therapyBright light (10,000 lux) therapy will be administered via a light box. | Other | Light therapy |
Primary outcome
Number of adverse events
Time frame: 2 weeks
The number of adverse events will be documented and categorized by organ system
6 secondary outcomes
Change in sleep quantity as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 2 weeks
Change in sleep efficiency as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 2 weeks
Change in overall sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline, 2 weeks
Change in insomnia severity as assessed by the Insomnia Severity Index (ISI)
Time frame: Baseline, 2 weeks
Change in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS)
Time frame: Baseline, 2 weeks
Change in fatigue severity as assessed by the Neuro-QoL fatigue questionnaire
Time frame: Baseline, 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn C Fitzgerald, ScD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Light therapy in people with Multiple Sclerosis, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.