Analyzing Sympathetic Activity in Willis-Ekbom Disease
Analysis of Sympathetic Activity in Willis-Ekbom Disease
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT02929732 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are French-speaking adults aged 18 to 75 with a diagnosis of idiopathic Willis-Ekbom disease and specific severity criteria.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Montpellier
- University Hospital of Montpellier — Montpellier, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.