Analysis of Sympathetic Activity in Willis-Ekbom Disease

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Oct 7, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a condition called Willis-Ekbom Disease (WED), which is often known as restless legs syndrome (RLS). People with WED experience uncomfortable feelings in their legs, especially at night, which can disrupt their sleep and overall quality of life. The researchers want to understand how WED affects the nervous system, particularly how it might cause an increase in blood pressure and heart rate during sleep. They will compare the nervous system activity of people with WED to that of healthy volunteers using special tests.

To participate in this study, you need to be between 18 and 75 years old, speak French, and be able to understand the study details. If you have WED, you should have specific symptoms and not have taken certain medications recently. Participants can expect to undergo some tests over a period of time to measure their heart and nervous system activity. This research could help uncover important links between WED and heart health, which is especially relevant for those with other risk factors like being older or having conditions like obesity or diabetes.

Gender

ALL

Eligibility criteria

• 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