NAPS-MS: NAtalizumab Effects on Parameters of Sleep in Patients With Relapsing Forms of Multiple Sclerosis Experiencing Fatigue or Sleepiness
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 3
- 主要终点
- Change in parameters of sleep as measured by polysomnography and multi-sleep latency test over 6 months of Natalizumab treatment.
研究概览
简要总结
The purpose of this study is to assess the impact of Natalizumab (Tysabri) therapy on sleep efficiency, total sleep time and sleep latency, in Multiple Sclerosis (MS) patients receiving Natalizumab for 6 months relative to baseline.
详细描述
Natalizumab has been shown to positively impact fatigue and cognition. The mechanism by which this occurs is unknown. Change in quality of sleep is one possible etiology of these findings. This study will help to elucidate the mechanisms that lead to reduced fatigue/sleepiness and less cognitive dysfunction in MS patients who go on Natalizumab therapy. Understanding these factors may help neurologists better differentiate between the different therapeutic options for MS and how they may impact symptoms that negatively affect quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsing form of multiple sclerosis
- •Able to give informed consent and committed to follow the protocol
- •EDSS from 0 to 6.0
- •Epworth Sleepiness Scale > 9 or Modified Fatigue Impact Scale > 30 or Fatigue Severity Scale > 4
- •Age range of 18 - 65 years of age
- •Naïve to Natalizumab
- •Enrolled in the TOUCH program
排除标准
- •Severe cognitive impairment
- •Coexisting severe medical condition
- •Inability to speak English or read
- •Inability to give valid informed consent.
研究组 & 干预措施
Natalizumab (Tysabri) naive
Patients who are newly prescribed Natalizumab (TYSABRI®), but have not received their first infusion, will be invited to participate.
干预措施: Natalizumab (Tysabri) (Drug)
结局指标
主要结局
Change in parameters of sleep as measured by polysomnography and multi-sleep latency test over 6 months of Natalizumab treatment.
时间窗: Baseline and 6 months
次要结局
- Change in neurocognition parameters over 6 months of Natalizumab treatment and correlation with changes in sleep efficiency.(Baseline and 6 months)
- Change in subjective measures of fatigue, sleepiness and mood over 6 months of Natalizumab treatment and correlation with changes in sleep efficiency.(Baseline and 6 months)