Clinical Features Associated With Restless Legs Syndrome. (Clin-RLS)

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.

Study Overview

• Status: Recruiting
• Conditions: Restless Legs Syndrome

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Sofiene Chenini, MD; Phone Number: 33 467332237; Email: sofienechenini@hotmail.com
• Study Contact Backup: Name: Yves DAUVILLIERS, MD PhD; Phone Number: 33 467337478; Email: y-dauvilliers@chu-montpellier.fr

Study Locations

• France
  • Montpellier, France, 34295
    • Recruiting
    • UHMontpellier
    • Contact: Sofiene Chenini, MD; Phone Number: 33 467332237; Email: sofienechenini@hotmail.com
    • Contact: Yves DAUVILLIERS, MD PhD; Phone Number: 33 467337478; Email: y-dauvilliers@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with RLS who are members of the RLS patient association

Description

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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): September 1, 2026
• Study Completion (Anticipated): September 1, 2027

Study Registration Dates

• First Submitted: September 6, 2021
• First Submitted That Met QC Criteria: September 6, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Actual): September 24, 2021
• Last Update Submitted That Met QC Criteria: September 18, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Opiates; Restless legs syndrome; Augmentation syndrome; Dopamine agonists; Alpha 2 delta ligands
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Neurobehavioral Manifestations; Disease; Dyskinesias; Psychomotor Disorders; Parasomnias; Syndrome; Psychomotor Agitation; Restless Legs Syndrome
• Other Study ID Numbers: RECHMPL21_0535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No