Clinical trial NCT05044520: Clinical Features Associated With Restless Legs Syndrome.
Official title: Clinical Features Associated With Restless Legs Syndrome : Clin-RLS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Restless Legs Syndrome
Keywords: Restless legs syndrome
Augmentation syndrome
Dopamine agonists
Alpha 2 delta ligands
Opiates
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with RLS who are members of the RLS patient association

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.

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.

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)

Primary outcomes:
measure: International restless legs syndrome study group rating scale (IRLS)
timeFrame: Four minutes
Secondary outcomes:
measure: Restless Legs Syndrome-6 Scale (RLS-6)
timeFrame: two minutes
measure: Augmentation Severity Rating Scale (ASRS)
timeFrame: two minutes
measure: Epworth severity scale (ESS)
timeFrame: two minutes
measure: Insomnia Severity Index (ISI)
timeFrame: two minutes
measure: Beck's Depression Inventory - II (BDI-II)
timeFrame: Six minute
measure: European Quality of life - 5 dimensions (EQ-5D)
timeFrame: One minute
measure: Homemade questionnaire assessing the falling risk
timeFrame: Five minutes
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Yves DAUVILLIERS, MD PhD
role: STUDY_DIRECTOR
References: