[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492731":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":36,"centralContacts":44,"locations":54,"responsibleParty":72,"collaborators":11,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":11,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":57,"whyStopped":11,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University Hospital, Bordeaux","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Restless Legs Syndrome","EXPERIMENTAL",null,[13,14,15,16],"Other: Clinical assessment","Behavioral: auto-questionnaires","Device: Ecological Momentary Assessment (EMA)","Device: activity-rest cycle",[18,22,27,32],{"type":6,"name":19,"description":20,"armGroupLabels":21,"otherNames":11},"Clinical assessment","RLS history, RLS treatments, and International Restless Legs Syndrome Rating Scale (IRLSRS) will be recorded",[9],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":11},"BEHAVIORAL","auto-questionnaires","To evaluate sleep quality, daytime somnolence and mood disorders (Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI), Epworth Sleepiness Scale (ESS) and Hospital Anxiety and Depression Scale (HADS)).",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"DEVICE","Ecological Momentary Assessment (EMA)","4 electronic interviews administred per day during 14 days by a study-dedicated Android OS smartphone",[9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"activity-rest cycle","To further investigate the mutual influence of sleep quality on RLS symptoms and mood, the activity-rest cycle will be monitored by wearable actigraph to be placed on the non-dominant wrist during a period of 13 days and 14 nights.",[9],[37,40],{"name":38,"affiliation":5,"role":39},"Imad Marc Antoine GHORAYEB, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":41,"affiliation":42,"role":43},"Gwénaëlle CATHELINE, PhD","Université de Bordeaux - INCIA","STUDY_CHAIR",[45,50],{"name":38,"role":46,"phone":47,"phoneExt":48,"email":49},"CONTACT","(0)5.56.79.55.13","+33","marc-antoine.ghorayeb@chu-bordeaux.fr",{"name":51,"role":46,"phone":52,"phoneExt":48,"email":53},"Olivier BRANCHARD","(0)5.57.82.06.97","olivier.branchard@chu-bordeaux.fr",[55],{"facility":56,"status":57,"city":58,"state":11,"zip":11,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"CHU de Bordeaux - Neurophysiologie Clinique de l'Enfant et de l'Adulte","RECRUITING","Bordeaux","France","FR",{"type":62,"coordinates":63},"Point",[64,65],-0.58046,44.84124,{"lat":65,"lon":64},[68,70,71],{"name":69,"role":46,"phone":47,"phoneExt":48,"email":49},"Imad Marc-Antoine GHORAYEB, MD, PhD",{"name":51,"role":46,"phone":52,"phoneExt":48,"email":53},{"name":69,"role":39,"phone":11,"phoneExt":11,"email":11},{"type":73,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100492731","ecological-momentary-assessment-in-patients-with-restless-legs-syndrome-100492731",false,"NCT05695963","Ecological Momentary Assessment in Patients With Restless Legs Syndrome","Feasibility, Validity and Clinical Utility of Ecological Momentary Assessment in Patients With Restless Legs Syndrome: a Prospective Study. DAILY-REST","DAILY-REST","Inclusion Criteria:\n\n* Patient over 18 years old and less than 70\n* Any patient with a diagnosis of idiopathic RLS based on medical history and the presence of the 5 RLS diagnostic criteria\n* Normal clinical examination\n* Person affiliated or benefiting from a social security scheme\n* 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).\n\nExclusion Criteria:\n\n* Any significant psychiatric illness (schizophrenia, bipolar disorder, severe depression, dementia, obsessive compulsive disorder, attention-deficit\u002Fhyperactivity disorder ...) or mood disorder\n* History or presence of chronic pain other than that associated with RLS, history of epilepsy or serious head injury, history of peripheral neuropathy, diabetes\n* Clinically significant sleep apnea, narcolepsy, or any secondary causes of RLS (e.g. chronic renal failure\u002Fhemodialysis, pregnancy)\n* 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\n* Pregnant or breastfeeding woman\n* 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).","ALL","18 Years","70 Years",{"count":86,"type":87},62,"ESTIMATED","INTERVENTIONAL",[90],"NA","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.",[9],[9,94,95,96,97,98],"Risk Factor","Ecological Momentary Assessment","Mobile Technology","Sleep","Actigraphy","2025-11-19",{"date":101,"type":102},"2025-11-20","ACTUAL",{"date":104,"type":102},"2024-01-15",{"date":106,"type":87},"2027-01",{"name":5,"class":6},1]