Restless Legs Syndrome Clinical Trial
— Clin-RLSOfficial title:
Clinical Features Associated With Restless Legs Syndrome : Clin-RLS
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.
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | September 1, 2027 |
Est. primary completion date | September 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
France | Uhmontpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | International restless legs syndrome study group rating scale (IRLS) | International restless legs syndrome study group rating scale (IRLS). ranging from 0 to 40, with higher scores indicating worse restless legs symptoms | Four minutes | |
Secondary | Restless Legs Syndrome-6 Scale (RLS-6) | 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 | two minutes | |
Secondary | Augmentation Severity Rating Scale (ASRS) | Augmentation Severity Rating Scale (ASRS). ranging from 0 to 24, with higher scores indicating worse augmentation symptoms | two minutes | |
Secondary | Epworth severity scale (ESS) | Epworth severity scale (ESS). ranging from 0 to 24, with higher scores indicating worse sleepiness | two minutes | |
Secondary | Insomnia Severity Index (ISI) | Insomnia Severity Index (ISI). ranging from 0 to 28, with higher scores indicating worse insomnia | two minutes | |
Secondary | Beck's Depression Inventory - II (BDI-II) | Beck's Depression Inventory - II (BDI-II). ranging from 0 to 63, with higher scores indicating worse depressive symptoms | Six minute | |
Secondary | European Quality of life - 5 dimensions (EQ-5D) | European Quality of life - 5 dimensions (EQ-5D). ranging from 0 to 100. Higher scores indicate better health condition | One minute | |
Secondary | Homemade questionnaire assessing the falling risk | Homemade questionnaire assessing the falling risk. ranging from 0 to 6, with higher scores indicating worse falling risk | Five minutes |
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