Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT05695963

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

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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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered 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

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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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