跳至主要内容
临床试验/NCT04603196
NCT04603196招募中不适用

Prevalence and Impact of Obstructive Sleep Apnea in Multiple Sclerosis

Beth Israel Deaconess Medical Center2 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2019年6月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
800
试验地点
2
主要终点
Home Sleep Study Data

研究概览

简要总结

This study will evaluate the influence of sleep apnea on clinical and radiological features of MS. Sleep apnea is associated with hypoxemia during sleep, which is likely detrimental to MS. Clinical data (MRI, lab results, medical history, labs, and sleep studies) of MS patients will be collected and analyzed. This will be done to study correlations between MRI, clinical data, lab studies and sleep studies. There is specific interest in the type of sleep apnea associated with MS, and whether MRI or clinical metrics of MS severity correlate with presence or absence of sleep apnea.

详细描述

BACKGROUND Multiple sclerosis (MS) is an inflammatory demyelinating neurologic disease associated with significant disability. Many pathological mechanisms are believed to drive MS, including inflammation. However, the mechanism behind progression, the major driver of disability in MS, is thought to be distinctly different. With progression, neurodegeneration and loss of neurons/axons appears to be primarily responsible. A theory of "virtual hypoxia" has been theorized, in that inflammation and demyelination cause neurons and axons to work harder, utilizing more energy. The overuse of neuron/axon energy makes it more likely that there are periods of low/absent energy availability, which drives neuron/axon degeneration and progression in MS.

It is well known that MS is associated with sleep apnea. Obstructive sleep apnea (OSA) prevalence in MS patients is approximately 58%. Sleep apnea is a disorder where lower blood oxygenation occurs during sleep. Since it is probable that low blood oxygenation would contribute to neuron/axon injury, it is possible MS patients with sleep apnea have worse neurological outcomes (clinically and radiographically).

It is possible that testing can show an effect on neuron/axon injury as well as inflammation. In addition to MRI changes that correlate with these changes, there are blood markers of neurodegeneration and inflammation including neurofilament-light (NFL) and glial fibrillary acidic protein (GFAP), now available for blood testing commercially. Elevations in such markers may be associated with sleep apnea.

This study will enable a first approximation of the prevalence of sleep apnea in MS as well as associated features of the comorbidity.

Patients will undergo a Home Sleep Test study using an at home polysomnagraphy device to help determine an accurate prevalence rate of sleep apnea in the MS population. Patients will also answer questionnaires to gain qualitative data on fatigue, sleepiness, sleep quality, restless leg syndrome risk, pain, sleep apnea risk, depression, and anxiety. Lastly, blood samples will be collected to study markers of neurodegeneration and inflammation.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Written consent
  • Over age 18
  • Confirmed diagnosis of multiple sclerosis

排除标准

  • cannot provide informed consent

结局指标

主要结局

Home Sleep Study Data

时间窗: 1 year

Home Sleep Study Data

次要结局

  • Questionnaire data(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacob Sloane

Assistant Professor of Neurology

Beth Israel Deaconess Medical Center

研究点 (2)

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