Clin-RLS: Clinical Features Associated With Restless Legs Syndrome.

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Recruiting
CT.gov ID
NCT05044520
Collaborator
(none)
2,000
1
72
27.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Clinical Features Associated With Restless Legs Syndrome : Clin-RLS
    Actual Study Start Date :
    Sep 1, 2021
    Anticipated Primary Completion Date :
    Sep 1, 2026
    Anticipated Study Completion Date :
    Sep 1, 2027

    Outcome Measures

    Primary Outcome Measures

    1. International restless legs syndrome study group rating scale (IRLS) [Four minutes]

      International restless legs syndrome study group rating scale (IRLS). ranging from 0 to 40, with higher scores indicating worse restless legs symptoms

    Secondary Outcome Measures

    1. Restless Legs Syndrome-6 Scale (RLS-6) [two minutes]

      Restless Legs Syndrome-6 Scale (RLS-6)symptoms after a surgical procedure under general or locoregional anesthesia. ranging from 0 to 60, with higher scores indicating worse restless legs symptoms

    2. Augmentation Severity Rating Scale (ASRS) [two minutes]

      Augmentation Severity Rating Scale (ASRS). ranging from 0 to 24, with higher scores indicating worse augmentation symptoms

    3. Epworth severity scale (ESS) [two minutes]

      Epworth severity scale (ESS). ranging from 0 to 24, with higher scores indicating worse sleepiness

    4. Insomnia Severity Index (ISI) [two minutes]

      Insomnia Severity Index (ISI). ranging from 0 to 28, with higher scores indicating worse insomnia

    5. Beck's Depression Inventory - II (BDI-II) [Six minute]

      Beck's Depression Inventory - II (BDI-II). ranging from 0 to 63, with higher scores indicating worse depressive symptoms

    6. European Quality of life - 5 dimensions (EQ-5D) [One minute]

      European Quality of life - 5 dimensions (EQ-5D). ranging from 0 to 100. Higher scores indicate better health condition

    7. Homemade questionnaire assessing the falling risk [Five minutes]

      Homemade questionnaire assessing the falling risk. ranging from 0 to 6, with higher scores indicating worse falling risk

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Study Director: Yves DAUVILLIERS, MD PhD, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT05044520
    Other Study ID Numbers:
    • RECHMPL21_0535
    First Posted:
    Sep 14, 2021
    Last Update Posted:
    Sep 24, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 24, 2021