Clinical Features Associated With Restless Legs Syndrome.

Recruiting

• Conditions: Restless Legs Syndrome

• Registration Number: NCT05044520
• Lead Sponsor: University Hospital, Montpellier

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.

Study Timeline

• Status Verified: 2021-09
• Study Start: 2021-09-01
• Study First Submitted: 2021-09-06
• Study First Submitted QC: 2021-09-06
• Study First Posted: 2021-09-14
• Last Update Submitted: 2021-09-18
• Last Update Posted: 2021-09-24
• Primary Completion: 2026-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Augmentation Severity Rating Scale (ASRS)	two minutes	Augmentation Severity Rating Scale (ASRS). ranging from 0 to 24, with higher scores indicating worse augmentation symptoms
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
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
Insomnia Severity Index (ISI)	two minutes	Insomnia Severity Index (ISI). ranging from 0 to 28, with higher scores indicating worse insomnia
Epworth severity scale (ESS)	two minutes	Epworth severity scale (ESS). ranging from 0 to 24, with higher scores indicating worse sleepiness
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

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France