An observational study in RLS, sponsored by University Hospital, Clermont-Ferrand. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by University Hospital, Clermont-Ferrand · Observational
Restless Legs Syndrome (RLS) is a neurological disorder affecting between 4% and 29% of adults. It is characterized by an urge to move the legs or other parts of the body, often accompanied by unpleasant and sometimes painful sensations. The pathophysiology of RLS, whether associated with pain or not, remains poorly understood, and only a limited number of studies have specifically investigated this aspect.
The aim of this study is to determine the prevalence of the painful component of symptoms in a large cohort of patients with RLS, to further characterize its clinical features, and to assess its impact on patients' quality of life. This work could improve the identification of patients experiencing pain, enhance our understanding of pain characteristics in RLS, and help optimize patient management. Furthermore, in the context of emerging therapeutic approaches such as neuromodulation, a better characterization of pain in RLS may contribute to the development and evaluation of new treatment strategies. This is particularly relevant given the high prevalence of RLS and its substantial impact on patients' quality of life.
Participants will be recruited either through their neurologist during routine follow-up visits at the Neurology Department of Clermont-Ferrand University Hospital or through the France Ekbom Association. Individuals interested in participating will be provided with access to the online questionnaire via a QR code or a dedicated web link. One thousand patients will be include in this study (RIPH type 3). The online questionnaire is expected to take approximately 30 minutes to complete. It includes the collection of demographic data (age, sex, lifestyle factors, weight, height, employment status, comorbidities, and dietary habits), as well as questions regarding the patient's medical history and sleep habits.
The questionnaire also includes validated instruments assessing sleep, pain, RLS severity, anxiety and depression, and quality of life.
At the end of the questionnaire, participants will be invited to take part in an optional ancillary study aimed at validating the French translation of the Restless Legs Syndrome Quality of Life questionnaire (RLS-QOL). Participants who agree to participate will complete the questionnaire once at baseline and will subsequently receive an email reminder to complete it a second time two weeks later. This test-retest procedure will be used to assess the reproducibility of the French-adapted version of the questionnaire.
2,216 studies on the registry are indexed under Pain; 915 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 107 across 270 observational studies indexed under Pain.
Browse Pain studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients will be contacted through the France Ekbom Association or identified during routine consultations. Those who are interested in participating in the study will be able to access the online questionnaire via a QR code or a web link.
Exclusion Criteria:
Patients with a diagnosis of Restless Legs Syndrome (RLS) confirmed by a sleep specialist
Other: Patients with RLS
The online questionnaire is expected to take approximately 30 minutes to complete. It includes the collection of demographic data (age, sex, lifestyle factors, weight, height, employment status, comorbidities, and dietary habits), as well as questions regarding the patient's medical history and sleep habits. The questionnaire also includes validated instruments assessing sleep, pain, RLS severity, anxiety and depression, and quality of life. At the end of the questionnaire, participants will be invited to take part in an optional ancillary study aimed at validating the French translation of the Restless Legs Syndrome Quality of Life questionnaire (RLS-QOL). Participants who agree to participate will complete the questionnaire once at baseline and will subsequently receive an email reminder to complete it a second time two weeks later.
Pain evaluation according to the Brief Pain Inventory (PBI)
Time frame: at day 0
Pain characteristics using the DN4 questionnaire
Time frame: at day 0
RLS severity using the International Restless Legs Syndrome Rating Scale (IRLS)
Time frame: at day 0
Fibromyalgia using the FIRST (Fibromyalgia Rapid Screening Tool)
Time frame: at day 0
Biopsychosocial dimensions of pain according to the Pain Catastrophizing Scale (PCS).
Time frame: at day 0
Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS)
Time frame: at day 0
Quality of life using the EQ-5D-5L
Time frame: at day 0
Daytime sleepiness using Epworth Sleepiness Scale (ESS).
Time frame: at day 0
RLS-specific quality of life using the Restless Legs Syndrome Quality of Life questionnaire (RLS-QOL).
Time frame: at day 0
Plan to share: No
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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University Hospital, Clermont-Ferrand