Using mobile technology to assess symptoms in patients with Restless Legs Syndrome

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to explore the feasibility of using mobile technology to collect real-time data on symptom severity fluctuations in patients with Restless Legs Syndrome (RLS). By employing Ecological Momentary Assessment (EMA), the study will gather information on daily life risk factors that may influence the onset or worsening of RLS symptoms. The research will focus on understanding how health-related behaviors, such as physical activity and sleep quality, impact the condition. The ultimate goal is to provide insights that could lead to improved management strategies for RLS.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient over 18 years old and less than 70
* Any patient with a diagnosis of idiopathic RLS based on medical history and the presence of the 5 RLS diagnostic criteria
* Normal clinical examination
* Person affiliated or benefiting from a social security scheme
* Free, informed and written consent signed by the participant and the investigator (no later than the day of inclusion and prior to any review required by the research).

Exclusion Criteria:

* Any significant psychiatric illness (schizophrenia, bipolar disorder, severe depression, dementia, obsessive compulsive disorder, attention-deficit/hyperactivity disorder ...) or mood disorder
* History or presence of chronic pain other than that associated with RLS, history of epilepsy or serious head injury, history of peripheral neuropathy, diabetes
* Clinically significant sleep apnea, narcolepsy, or any secondary causes of RLS (e.g. chronic renal failure/hemodialysis, pregnancy)
* Other active clinically significant illness, including unstable cardiovascular, or neoplasic pathology which could interfere with the study conduct or interfere with study assessments or compromise the study participation
* Pregnant or breastfeeding woman
* Persons referred to in articles L.1121-5 to L.1121-8 (persons deprived of liberty by judicial or administrative decision, minors, adults subject to a legal protection measure or unable to express their consent).

Where it's running

• CHU de Bordeaux - Neurophysiologie Clinique de l'Enfant et de l'Adulte
  Bordeaux, France Recruiting

Study contacts

• Principal investigator: Imad Marc Antoine GHORAYEB, MD, PhD — University Hospital, Bordeaux
• Study coordinator: Imad Marc Antoine GHORAYEB, MD, PhD
• Email: marc-antoine.ghorayeb@chu-bordeaux.fr
• Phone: (0)5.56.79.55.13

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.