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Analysis of Sympathetic Activity in Willis-Ekbom Disease

RecruitingNAAges 18 Years - 74 YearsAllUniversity Hospital, Montpellier
NCT02929732 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Willis-Ekbom disease (WED), also known as restless legs syndrome (RLS) is a common neurological sensorimotor disorder that typically impairs sleep and quality of life, likely consequent to a central dopaminergic dysfunction associated to brain iron deficiency. Periodic limb movements (PLMS) in sleep are present in 80% of patients with WED. PLMS are often associated with micro-arousals that contribute to sleep fragmentation and repeated increases of blood pressure and heart rate throughout the night, thus representing an increased risk for hypertension and cardiovascular diseases (CVD). Willis-Ekbom disease affects people with higher cardiovascular risk factors, such as advanced age, obesity, diabetes mellitus and hypercholesterolemia. However, previous observational, cross-sectional or longitudinal population-based studies on the association between RLS and CVD and hypertension showed c

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📋 Eligibility rules (as published)
Inclusion Criteria: * Non-specific inclusion criteria (CASE + CONTROL) * 18 years-old or more, and less than 75 years-old * French-speaking * able to understand the study * signed written informed consent * affiliated to social security * CASE-specific inclusion criteria * 5 " International RLS Study Group (IRLSSG) 2012 " positive criteria * RLS severity scale (IRLS) score ≥ 15 * ferritin \> 50 ng/ml * periodic limb movements index \> 10/hour * idiopathic (or primary) Willis-Ekbom disease not treated with dopaminergic agonists or pregabalin or gabapentin in the last 8 days, at least 3 years of disease duration with symptoms recurring at least 3 times a week Exclusion Criteria: * Non-specific exclusion criteria (CASE + CONTROL) * vulnerable subject : subject deprived of liberty or protected by law (trusteeship, legal guardianship), pregnant or breastfeeding woman * exclusion period after other research protocol * malignant neoplastic disease treated in the last 12 months * medical history of cardiovascular disease (ischemic heart disease, heart failure, stroke, hypertension, sleep apnea syndrome) * antidepressant, neuroleptic, sympathomimetic, sympatholytic, vasculotropic, dopamine agonists, opiate treatments * CASE-specific exclusion criteria \- restless legs syndrome secondary to renal failure, hemochromatosis, neurologic disorders, iatrogenesis * CONTROL-specific exclusion criteria - Willis-Ekbom Disease
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What it tests

  • Sympathetic nervous activity measurement
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Where

1 site
University Hospital of Montpellier
Montpellier, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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