Clinical Features Associated With Restless Legs Syndrome.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults subjects

Restless legs syndrome diagnosis

Member of the restless legs syndrome association

French speaking

Disqualifiers

None

Trial population

Patients with RLS who are members of the RLS patient association

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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

Time frame
Four minutes

Secondary outcomes

1

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

Time frame
two minutes
2

Augmentation Severity Rating Scale (ASRS)

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

Time frame
two minutes
3

Epworth severity scale (ESS)

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

Time frame
two minutes
4

Insomnia Severity Index (ISI)

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

Time frame
two minutes

Other outcomes

Sponsors and contacts

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