Actively Recruiting
Ecological Momentary Assessment in Patients With Restless Legs Syndrome
Led by University Hospital, Bordeaux · Updated on 2025-11-20
62
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The Restless Legs Syndrome (RLS) is a sensorimotor disorder better characterized by an urge to move the legs at rest. Although treatments are available, many patients experience periods of symptoms relief and exacerbation. Whether this is due to the natural history of the disease or to health-related behaviors of daily life is presently unknown. The primary objective is to examine the feasibility of mobile technology to assess RLS symptoms severity fluctuations in daily life by collecting real-time data. The secondary objectives will be to examine the validity of this technic in the context of RLS and to use these real-time data to identify daily life risk factors for symptom onset or aggravation.
CONDITIONS
Official Title
Ecological Momentary Assessment in Patients With Restless Legs Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 years old and less than 70
- Diagnosis of idiopathic Restless Legs Syndrome based on medical history and presence of the 5 RLS diagnostic criteria
- Normal clinical examination
- Affiliated with or benefiting from a social security scheme
- Signed free, informed, and written consent before participation
You will not qualify if you...
- Significant psychiatric illness such as schizophrenia, bipolar disorder, severe depression, dementia, obsessive compulsive disorder, or attention-deficit/hyperactivity disorder
- History or presence of chronic pain other than that associated with RLS, epilepsy, serious head injury, peripheral neuropathy, or diabetes
- Clinically significant sleep apnea, narcolepsy, or secondary causes of RLS such as chronic renal failure, hemodialysis, or pregnancy
- Other active clinically significant illnesses including unstable cardiovascular or neoplastic diseases that could interfere with the study
- Pregnant or breastfeeding women
- Persons deprived of liberty, minors, adults under legal protection, or unable to give consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU de Bordeaux - Neurophysiologie Clinique de l'Enfant et de l'Adulte
Bordeaux, France
Actively Recruiting
Research Team
I
Imad Marc Antoine GHORAYEB, MD, PhD
CONTACT
O
Olivier BRANCHARD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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