跳至主要内容
临床试验/NCT05044520
NCT05044520招募中不适用

Clinical Features Associated With Restless Legs Syndrome : Clin-RLS

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2021年9月1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
2,000
试验地点
1
主要终点
International restless legs syndrome study group rating scale (IRLS)

研究概览

简要总结

Restless legs syndrome (RLS) is a chronic neurological disorder characterized by an urge to move the legs at night when at rest. RLS can lead to a sleep deprivation, increased falling risk, daytime sleepiness, depression and decreased quality of life. Dopamine agonists, alpha-2-delta ligands and opiates are key medications for RLS. The natural course of RLS is very heterogeneous with a risk of increasing the severity of symptoms over the years despite the use of drugs and recommended dosages. Many comorbidities can make RLS worse. Augmentation syndrome is the main complication of dopamine agonists. However, only a few studies have addressed the clinical, biological and pharmacological factors associated with the evolution of the severity of RLS. The objective of this study is to assess the evolution of RLS symptoms severity as function of RLS phenotype, comorbidities and RLS medication, in large cohort of members of the French RLS association and other European RLS association.

详细描述

In this study, the investigators want to study the clinical course of RLS in a population of RLS patients who are members of the RLS patient association, taking into account clinical and biological factors as well as the treatments taken for RLS.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

International restless legs syndrome study group rating scale (IRLS)

时间窗: Four minutes

International restless legs syndrome study group rating scale (IRLS). ranging from 0 to 40, with higher scores indicating worse restless legs symptoms

次要结局

  • European Quality of life - 5 dimensions (EQ-5D)(One minute)
  • Augmentation Severity Rating Scale (ASRS)(two minutes)
  • Beck's Depression Inventory - II (BDI-II)(Six minute)
  • Restless Legs Syndrome-6 Scale (RLS-6)(two minutes)
  • Insomnia Severity Index (ISI)(two minutes)
  • Epworth severity scale (ESS)(two minutes)
  • Homemade questionnaire assessing the falling risk(Five minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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