Clinical trial Recruiting at 1 site Interventional Ages 18 to 74

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 typeInterventional
Ages18 Years to 74 Years
SexAll
Enrollment40 (estimated)
SponsorUniversity Hospital, Montpellier
Academic / other
Locations1 site (Montpellier)
StatusRecruiting
StartedMarch 21, 2017
Main results expectedOctober 5, 2027
Study endsOctober 5, 2027
Registry record updatedOctober 2, 2025
Trial IDNCT02929732 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

  • University Hospital of Montpellier
    Montpellier, France
    Recruiting

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.