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NCT Number: NCT05044520

Clinical Features Associated With Restless Legs Syndrome.

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.

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Key information

Conditions

Restless Legs Syndrome Dyssomnias Mental Disorders Nervous System Diseases Parasomnias Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. International restless legs syndrome study group rating scale (IRLS)

    Time frame: 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 outcomes

  1. Restless Legs Syndrome-6 Scale (RLS-6)

    Time frame: 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

  2. Augmentation Severity Rating Scale (ASRS)

    Time frame: two minutes

    Augmentation Severity Rating Scale (ASRS). ranging from 0 to 24, with higher scores indicating worse augmentation symptoms

  3. Epworth severity scale (ESS)

    Time frame: two minutes

    Epworth severity scale (ESS). ranging from 0 to 24, with higher scores indicating worse sleepiness

  4. Insomnia Severity Index (ISI)

    Time frame: two minutes

    Insomnia Severity Index (ISI). ranging from 0 to 28, with higher scores indicating worse insomnia

  5. Beck's Depression Inventory - II (BDI-II)

    Time frame: Six minute

    Beck's Depression Inventory - II (BDI-II). ranging from 0 to 63, with higher scores indicating worse depressive symptoms

  6. European Quality of life - 5 dimensions (EQ-5D)

    Time frame: One minute

    European Quality of life - 5 dimensions (EQ-5D). ranging from 0 to 100. Higher scores indicate better health condition

  7. Homemade questionnaire assessing the falling risk

    Time frame: Five minutes

    Homemade questionnaire assessing the falling risk. ranging from 0 to 6, with higher scores indicating worse falling risk

Study contacts

Contact information is provided by the study sponsor or research team.

Sofiene Chenini, MD

CONTACT

[email protected]

467332237 ext. 33

Yves DAUVILLIERS, MD PhD

CONTACT

[email protected]

467337478 ext. 33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Clinical Features Associated With Restless Legs Syndrome : Clin-RLS

Acronym: Clin-RLS

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Sep 14, 2021
Registry last updated
Sep 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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