Bright Light Therapy for Sleep Disturbance in People With Multiple Sclerosis

January 9, 2024 updated by: Johns Hopkins University
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Light therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adverse events
Time Frame: 2 weeks
The number of adverse events will be documented and categorized by organ system
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sleep quantity as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, 2 weeks
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.
Baseline, 2 weeks
Change in sleep efficiency as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, 2 weeks
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.
Baseline, 2 weeks
Change in overall sleep quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, 2 weeks
The PSQI has an overall score that ranges from 0 to 21. The investigators will assess change in the overall PSQI score.
Baseline, 2 weeks
Change in sleep efficiency as assessed by actigraphy
Time Frame: Baseline, 2 weeks
Change in sleep efficiency is calculated as time sleeping divided by time in bed which is measured by actigraphy.
Baseline, 2 weeks
Change in total sleep time
Time Frame: Baseline, 2 weeks
Change in total sleep time (minutes) as quantified by actigraphy
Baseline, 2 weeks
Change in insomnia severity as assessed by the Insomnia Severity Index (ISI)
Time Frame: Baseline, 2 weeks
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.
Baseline, 2 weeks
Change in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS)
Time Frame: Baseline, 2 weeks
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.
Baseline, 2 weeks
Change in fatigue severity as assessed by the Neuro-QoL fatigue questionnaire
Time Frame: Baseline, 2 weeks
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.
Baseline, 2 weeks
Change in function of intrinsically photosensitive retinal ganglion cells
Time Frame: Baseline, 2 weeks
Change in function of intrinsically photosensitive retinal ganglion cells as quantified by the relative change in pupillary light response to blue light.
Baseline, 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Minority Health and Health Disparities (NIMHD)

Investigators

  • Principal Investigator: Kathryn C Fitzgerald, ScD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2021

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

January 30, 2025

Study Registration Dates

First Submitted

August 9, 2019

First Submitted That Met QC Criteria

August 9, 2019

First Posted (Actual)

August 13, 2019

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00222887
  • R03HD101056 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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