Actively Recruiting
Feasibility, Validity and Clinical Utility of Ecological Momentary Assessment in Patients With Restless Legs Syndrome: a Prospective Study. DAILY-REST
Led by University Hospital, Bordeaux · Updated on 2025-11-20
62
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying Restless Legs Syndrome (RLS), a disorder marked by an urge to move the legs at rest, often disturbing sleep and quality of life. This study aims to assess the feasibility and validity of using mobile technology to monitor fluctuations in RLS symptoms in real time and to identify daily life risk factors that may trigger or worsen symptoms. The study is prospective and focuses on evaluating ecological momentary assessment (EMA) as a tool for understanding symptom changes. Participants will receive a study-dedicated smartphone to complete four electronic interviews daily over a two-week period, alongside wearing a wrist actigraph to monitor activity and rest cycles. The study combines clinical assessments, behavioral questionnaires on sleep and mood, and continuous electronic symptom tracking to gather comprehensive data on RLS symptoms and their possible triggers. Throughout the study, participants will undergo clinical evaluations and complete questionnaires assessing sleep quality, daytime sleepiness, and mood disorders. Researchers will monitor activity-rest cycles with a wearable device during the 13-day, 14-night period. The primary outcome is the feasibility of EMA after 14 days, with secondary outcomes including its validity and identification of risk factors for symptom onset or worsening. Participation will last approximately two weeks, during which real-time data collection and monitoring will occur.
CONDITIONS
Brief 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 5 diagnostic criteria
- Normal clinical examination
- Affiliated or benefiting from a social security scheme
- Free, informed, and written consent signed by participant and investigator
You will not qualify if you...
- Significant psychiatric illness such as schizophrenia, bipolar disorder, severe depression, dementia, OCD, or ADHD
- History or presence of chronic pain unrelated to RLS, epilepsy, serious head injury, peripheral neuropathy, or diabetes
- Clinically significant sleep apnea, narcolepsy, or secondary causes of RLS like chronic renal failure or pregnancy
- Other active clinically significant illnesses including unstable cardiovascular or neoplastic diseases
- Pregnant or breastfeeding women
- Persons deprived of liberty, minors, adults under legal protection, or unable to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 14 days
Participants carry a study-dedicated smartphone to complete 4 electronic interviews per day and wear an actigraph on the non-dominant wrist to monitor their activity-rest cycle over about two weeks.
Daily electronic interviews and continuous wearable monitoring for 14 days
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
O
Olivier BRANCHARD
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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