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临床试验/NCT04054050
NCT04054050已完成不适用

Bright Light Therapy for Sleep Disturbance in People With Multiple Sclerosis

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2021年2月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
27
试验地点
1
主要终点
Number of adverse events

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

研究组 & 干预措施

Light therapy

Experimental

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

干预措施: Light therapy (Other)

结局指标

主要结局

Number of adverse events

时间窗: 2 weeks

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

次要结局

  • Change in sleep quantity 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 insomnia severity as assessed by the Insomnia Severity Index (ISI)(Baseline, 2 weeks)
  • Change in function of intrinsically photosensitive retinal ganglion cells(Baseline, 2 weeks)
  • Change in total sleep time(Baseline, 2 weeks)
  • Change in fatigue severity as assessed by the Neuro-QoL fatigue questionnaire(Baseline, 2 weeks)
  • Change in sleep efficiency 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 daytime sleepiness as assessed by the Epworth Sleepiness Scale (ESS)(Baseline, 2 weeks)

研究者

发起方
Johns Hopkins University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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