Clinical Features Associated With Restless Legs Syndrome.

Restless Legs Syndrome Clinical Trial

— Clin-RLS  

Official title:

Clinical Features Associated With Restless Legs Syndrome : Clin-RLS

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05044520
• Other study ID #: RECHMPL21_0535
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: September 1, 2027

Study information

• Verified date: September 2021
• Source: University Hospital, Montpellier
• Contact: Sofiene Chenini, MD
• Phone: 467332237
• Email: sofienechenini[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome
• Syndrome

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

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