Analyzing Sympathetic Activity in Willis-Ekbom Disease
Official title: Analysis of Sympathetic Activity in Willis-Ekbom Disease
Run by University Hospital, Montpellier · NCT02929732 · Data updated 2026-11-12
This study is testing how the nervous system works in people with restless legs syndrome to see if it affects their heart health and sleep quality.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 74 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Status | Recruiting |
| Started | March 21, 2017 |
| Main results expected | October 5, 2027 |
| Study ends | October 5, 2027 |
| Registry record updated | October 2, 2025 |
| Trial ID | NCT02929732 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are French-speaking adults aged 18 to 75 with a diagnosis of idiopathic Willis-Ekbom disease and specific severity criteria.
✕Probably not a fit
Patients who are currently treated with dopaminergic agonists or certain other medications, or those with severe comorbid conditions, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the sympathetic nervous system activity in patients with Willis-Ekbom Disease (WED), also known as restless legs syndrome (RLS). It aims to understand the relationship between WED and cardiovascular risks by measuring sympathetic activity and its potential impact on sleep quality and overall health. Participants will include individuals diagnosed with idiopathic WED who meet specific inclusion criteria, and the study will utilize a case-control design to compare findings. The research seeks to clarify the pathophysiology of WED and its association with cardiovascular diseases.
Why it matters
Potential benefit: If successful, this study could lead to better understanding and management of restless legs syndrome, potentially improving sleep quality and reducing cardiovascular risks for patients.
How similar studies have gone: While there have been various studies on restless legs syndrome, this specific approach focusing on sympathetic activity in relation to cardiovascular risks is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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University Hospital of Montpellier
Montpellier, France Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.