NCT05695963 Ecological Momentary Assessment in Patients With Restless Legs Syndrome
| NCT ID | NCT05695963 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Restless Legs Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2024-01-15 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 62 participants in total. It began in 2024-01-15 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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).
Contact & Investigator
Imad Marc Antoine GHORAYEB, MD, PhD
PRINCIPAL INVESTIGATOR
University Hospital, Bordeaux
Frequently Asked Questions
Who can join the NCT05695963 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Restless Legs Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05695963 currently recruiting?
Yes, NCT05695963 is actively recruiting participants. Contact the research team at marc-antoine.ghorayeb@chu-bordeaux.fr for enrollment information.
Where is the NCT05695963 trial being conducted?
This trial is being conducted at Bordeaux, France.
Who is sponsoring the NCT05695963 clinical trial?
NCT05695963 is sponsored by University Hospital, Bordeaux. The principal investigator is Imad Marc Antoine GHORAYEB, MD, PhD at University Hospital, Bordeaux. The trial plans to enroll 62 participants.