Clinical Features Associated With Restless Legs Syndrome.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Restless Legs Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Clinical Features Associated With Restless Legs Syndrome : Clin-RLS
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.
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.
Primary outcome measures
- International restless legs syndrome study group rating scale (IRLS) [Time frame: Four minutes]
Secondary outcome measures (7)
- Restless Legs Syndrome-6 Scale (RLS-6) [Time frame: two minutes]
- Augmentation Severity Rating Scale (ASRS) [Time frame: two minutes]
- Epworth severity scale (ESS) [Time frame: two minutes]
- Insomnia Severity Index (ISI) [Time frame: two minutes]
- Beck's Depression Inventory - II (BDI-II) [Time frame: Six minute]
- European Quality of life - 5 dimensions (EQ-5D) [Time frame: One minute]
- Homemade questionnaire assessing the falling risk [Time frame: Five minutes]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Uhmontpellier — Montpellier
Identifiers
NCT: NCT05044520 · RECHMPL21_0535