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Restless legs linked to overactive nerves? new study investigates heart risk

NCT ID NCT02929732

Knowledge-focused Sponsor: University Hospital, Montpellier Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether people with Restless Legs Syndrome (also called Willis-Ekbom disease) have overactive nerve signals that could raise their risk for high blood pressure and heart disease. Researchers will measure heart nerve activity using a special scan, along with blood pressure and heart rate over 24 hours. The study involves 40 adults (20 with the condition and 20 healthy volunteers) and aims to understand the body's stress response during sleep. It is an observational study, not a treatment trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this study could clarify why people with Restless Legs Syndrome may have higher heart disease risk, pointing toward future prevention strategies.
What could go wrong
This is a small observational study (40 participants) that measures biological signals, not a treatment trial. It cannot prove cause and effect, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2017

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 74 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

restless legs syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Restless legs syndrome Willis-ekbom disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University Hospital of Montpellier

    RECRUITING

    Montpellier, 34295, France

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