Clinical Features Associated With Restless Legs Syndrome.

Overview

Restless legs syndrome (RLS) is a chronic neurological disorder characterized by an urge to move the legs at night when at rest. RLS can lead to a sleep deprivation, increased falling risk, daytime sleepiness, depression and decreased quality of life. Dopamine agonists, alpha-2-delta ligands and opiates are key medications for RLS. The natural course of RLS is very heterogeneous with a risk of increasing the severity of symptoms over the years despite the use of drugs and recommended dosages. Many comorbidities can make RLS worse. Augmentation syndrome is the main complication of dopamine agonists. However, only a few studies have addressed the clinical, biological and pharmacological factors associated with the evolution of the severity of RLS. The objective of this study is to assess the evolution of RLS symptoms severity as function of RLS phenotype, comorbidities and RLS medication, in large cohort of members of the French RLS association and other European RLS association.

Full Title of Study: “Caractéristiques Cliniques associées au Syndrome Des Jambes Sans Repos”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: September 1, 2026

Detailed Description

In this study, the investigators want to study the clinical course of RLS in a population of RLS patients who are members of the RLS patient association, taking into account clinical and biological factors as well as the treatments taken for RLS.

Clinical Trial Outcome Measures

Primary Measures

  • International restless legs syndrome study group rating scale (IRLS)
    • Time Frame: Four minutes
    • International restless legs syndrome study group rating scale (IRLS)

Secondary Measures

  • Restless Legs Syndrome-6 Scale (RLS-6)
    • Time Frame: two minutes
    • Restless Legs Syndrome-6 Scale (RLS-6)symptoms after a surgical procedure under general or locoregional anesthesia
  • Augmentation Severity Rating Scale (ASRS)
    • Time Frame: two minutes
    • Augmentation Severity Rating Scale (ASRS)
  • Epworth severity scale (ESS)
    • Time Frame: two minutes
    • Epworth severity scale (ESS)
  • Insomnia Severity Index (ISI)
    • Time Frame: two minutes
    • Insomnia Severity Index (ISI)
  • Beck’s Depression Inventory – II (BDI-II)
    • Time Frame: Six minute
    • Beck’s Depression Inventory – II (BDI-II)
  • European Quality of life – 5 dimensions (EQ-5D)
    • Time Frame: One minute
    • European Quality of life – 5 dimensions (EQ-5D)
  • Homemade questionnaire assessing the falling risk
    • Time Frame: Five minutes
    • Homemade questionnaire assessing the falling risk

Participating in This Clinical Trial

Inclusion Criteria

  • Adults subjects – Restless legs syndrome diagnosis – Member of the restless legs syndrome association – French speaking – Able to understand the study – Signed written informed consent – Affiliated to social security Exclusion criteria:

  • Vulnerable subject : subject deprived of liberty or protected by law (trusteeship, legal guardianship)

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Montpellier
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yves DAUVILLIERS, MD PhD, Study Director, University Hospital, Montpellier
  • Overall Contact(s)
    • Sofiene Chenini, MD, 467332237, sofienechenini@hotmail.com

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