Clinical Features Associated With Restless Legs Syndrome.

NCT05044520 | Recruiting

• 1 other identifier: RECHMPL21_0535
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Restless Legs Syndrome

Keywords

Restless legs syndrome; Augmentation syndrome; Dopamine agonists; Alpha 2 delta ligands; Opiates

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Restless Legs Syndrome-6 Scale (RLS-6)

  two minutes

• Augmentation Severity Rating Scale (ASRS)

  two minutes

• Epworth severity scale (ESS)

  two minutes

• Insomnia Severity Index (ISI)

  two minutes

• Beck's Depression Inventory - II (BDI-II)

  Six minute

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with RLS who are members of the RLS patient association

You may qualify if:

• 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

You may not qualify if:

• \- Vulnerable subject : subject deprived of liberty or protected by law (trusteeship, legal guardianship)

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Restless Legs Syndrome

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Study Officials

• Yves DAUVILLIERS, MD PhD

  University Hospital, Montpellier

  STUDY DIRECTOR

Central Study Contacts

Sofiene Chenini, MD

CONTACT

467332237; sofienechenini@hotmail.com

Yves DAUVILLIERS, MD PhD

CONTACT

467337478; y-dauvilliers@chu-montpellier.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 14, 2021
• Study Start: September 1, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 24, 2021

Record last verified: 2021-09

Locations

FR (1)