Clinical Assessment of Autonomic Functions by SCOPA-Autonomic Questionnaire in Patients With Restless Legs Syndrome: A Prospective Study in a Tertiary Care Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Age (years)
研究概览
简要总结
Restless legs syndrome (RLS) is a sensorimotor, sleep-related disorder characterized by urgency to move the legs during inactivity or resting state. Although the exact mechanism is not clearly understood, sleep disturbances and dopamine deficiency may regarded as a potential contributing factor for autonomic dysfunction. The objective of the study is to evaluate autonomic functions and determine possible associations between autonomic dysfunction with clinical factors in patients with RLS.
详细描述
Restless legs syndrome (RLS) also known as Willis- Ekbom disease, is a common sensorimotor, sleep-related disorder characterized by an unpleasant feeling with urgency to move the legs (or less commonly the arms) during inactivity or resting state.
Although, the clinical importance of autonomic involvement in patients with restless legs syndrome (RLS) remains incompletely understood, sleep disturbances and dopamine deficiency may regarded as a potential contributing factor for autonomic dysfunction.
Previous reports have described autonomic impairment including changes in nocturnal blood pressure and heart rate variability (HRV), gastrointestinal, urinary and sexual dysfunction in patients with RLS. Despite many studies about electrophysiological autonomic changes in RLS, number of studies exploring autonomic functions by using Scales for Outcomes in Parkinson's disease-Autonomic questionnaire (SCOPA-AUT) are limited.
In this study, the investigators plan to compare the presence of autonomic symptoms by using Scales for Outcomes in Parkinson's disease-Autonomic (SCOPA-AUT) questionnaire in drug- naive RLS patients to healthy controls. In addition, the investigators aim to evaluate possible associations between autonomic dysfunction with clinical factors in patients with RLS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 是
入选标准
- •For the patient group:
- •age >18, <65
- •newly diagnosed, drug naive patients with primary restless legs syndrome
- •For the control group:
- •age >18, <65
- •participants without chronic systemic disorder
排除标准
- •previous diagnosis of primary RLS
- •subjects with secondary RLS
- •concomitant use of drugs that could interfere with autonomic nervous system
- •individuals with a known acute/chronic medical disease
- •individuals with a minimental test score < 25/30
- •sleep disorders that could affect test performances
结局指标
主要结局
Age (years)
时间窗: 6 months
Correlation between autonomic dysfunction and age (years) in patients with restless legs syndrome noted.
Age of disease onset (years)
时间窗: 6 months
Correlation between autonomic dysfunction and age of disease onset (years) in patients with restless legs syndrome noted.
Disease duration (years)
时间窗: 6 months
Correlation between autonomic dysfunction and disease duration (years) in patients with restless legs syndrome noted.
Scales for Outcomes in Parkinson's disease-Autonomic questionnaire (SCOPA-AUT) (points)
时间窗: 6 months
Presence and severity of autonomic dysfunction noted by using Scales for Outcomes in Parkinson's disease-Autonomic questionnaire \[SCOPA-AUT, including six domains (gastrointestinal,urinary, cardiovascular, thermoregulatory, pupillomotor, and sexual) with 25-items and a 4 -point Likert-type scale ranging from 0 to 69\] in patients with restless legs syndrome vs. healthy controls.
Disease severity (as measured by International Restless Legs Scale) (points)
时间窗: 6 months
Correlation between autonomic dysfunction and disease severity (as measured by International Restless Legs Scale,5-point Likert-type scale ranging from 0 to 40; mild= 0-10; moderate= 11-20; severe= 21-30; very severe= 31-40) in patients with restless legs syndrome noted.
Excessive daytime sleepiness (as measured by Epworth Sleepiness scale) (points)
时间窗: 6 months
Correlation between autonomic dysfunction and excessive daytime sleepiness \[as measured by Epworth Sleepiness scale ,8-items with a 4-point Likert-type scale ( 0=would never doze,1=slight chance,2=moderate chance, 3= high chance) ranging from 0 to 24 points\] in patients with restless legs syndrome noted.
Body mass index (kg/m2)
时间窗: 6 months
Correlation between autonomic dysfunction and body mass index (kg/m2, as calculated by dividing weight in kilograms by their height in metres squared) in patients with restless legs syndrome noted.
次要结局
未报告次要终点
研究者
Sehnaz Basaran
Principal Investigator, Department of Neurology
Kocaeli Derince Education and Research Hospital