Bright Light Therapy for Sleep Disturbance in People With Multiple Sclerosis

CompletedNot a drug-phase studyMS (type not specified)NCT04054050

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Light therapy

What it measured

Main measures

  • Number of adverse events

    2 weeks

    Safety

Other measures (6)

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

    Baseline, 2 weeks

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

    Baseline, 2 weeks

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

    Baseline, 2 weeks

    Mood and sleep
  • Change in insomnia severity as assessed by the Insomnia Severity Index (ISI)

    Baseline, 2 weeks

    Mood and sleep
  • Change in daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS)

    Baseline, 2 weeks

    Mood and sleep
  • Change in fatigue severity as assessed by the Neuro-QoL fatigue questionnaire

    Baseline, 2 weeks

    FatigueQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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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History

    1. Started

      Feb 2021

    2. Main results due

      Dec 2025

    3. Finished

      Jan 2026

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