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Completed

NCT Number: NCT04054050

Bright Light Therapy for Sleep Disturbance in People With Multiple Sclerosis

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

light therapy

Other

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

Primary outcomes

  1. Number of adverse events

    Time frame: 2 weeks

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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

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

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Aug 13, 2019
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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