Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT05044520
Status:
RECRUITING
Last Update Posted:
2021-09-24
First Post:
2021-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Features Associated With Restless Legs Syndrome.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012148', 'term': 'Restless Legs Syndrome'}], 'ancestors': [{'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D020447', 'term': 'Parasomnias'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-18', 'studyFirstSubmitDate': '2021-09-06', 'studyFirstSubmitQcDate': '2021-09-06', 'lastUpdatePostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International restless legs syndrome study group rating scale (IRLS)', 'timeFrame': 'Four minutes', 'description': 'International restless legs syndrome study group rating scale (IRLS). ranging from 0 to 40, with higher scores indicating worse restless legs symptoms'}], 'secondaryOutcomes': [{'measure': 'Restless Legs Syndrome-6 Scale (RLS-6)', 'timeFrame': 'two minutes', 'description': 'Restless Legs Syndrome-6 Scale (RLS-6)symptoms after a surgical procedure under general or locoregional anesthesia. ranging from 0 to 60, with higher scores indicating worse restless legs symptoms'}, {'measure': 'Augmentation Severity Rating Scale (ASRS)', 'timeFrame': 'two minutes', 'description': 'Augmentation Severity Rating Scale (ASRS). ranging from 0 to 24, with higher scores indicating worse augmentation symptoms'}, {'measure': 'Epworth severity scale (ESS)', 'timeFrame': 'two minutes', 'description': 'Epworth severity scale (ESS). ranging from 0 to 24, with higher scores indicating worse sleepiness'}, {'measure': 'Insomnia Severity Index (ISI)', 'timeFrame': 'two minutes', 'description': 'Insomnia Severity Index (ISI). ranging from 0 to 28, with higher scores indicating worse insomnia'}, {'measure': "Beck's Depression Inventory - II (BDI-II)", 'timeFrame': 'Six minute', 'description': "Beck's Depression Inventory - II (BDI-II). ranging from 0 to 63, with higher scores indicating worse depressive symptoms"}, {'measure': 'European Quality of life - 5 dimensions (EQ-5D)', 'timeFrame': 'One minute', 'description': 'European Quality of life - 5 dimensions (EQ-5D). ranging from 0 to 100. Higher scores indicate better health condition'}, {'measure': 'Homemade questionnaire assessing the falling risk', 'timeFrame': 'Five minutes', 'description': 'Homemade questionnaire assessing the falling risk. ranging from 0 to 6, with higher scores indicating worse falling risk'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Restless legs syndrome', 'Augmentation syndrome', 'Dopamine agonists', 'Alpha 2 delta ligands', 'Opiates'], 'conditions': ['Restless Legs Syndrome']}, 'descriptionModule': {'briefSummary': 'Restless legs syndrome (RLS) is a chronic neurological disorder characterized by an urge to move the legs at night when at rest. RLS can lead to a sleep deprivation, increased falling risk, daytime sleepiness, depression and decreased quality of life. Dopamine agonists, alpha-2-delta ligands and opiates are key medications for RLS. The natural course of RLS is very heterogeneous with a risk of increasing the severity of symptoms over the years despite the use of drugs and recommended dosages. Many comorbidities can make RLS worse. Augmentation syndrome is the main complication of dopamine agonists. However, only a few studies have addressed the clinical, biological and pharmacological factors associated with the evolution of the severity of RLS. The objective of this study is to assess the evolution of RLS symptoms severity as function of RLS phenotype, comorbidities and RLS medication, in large cohort of members of the French RLS association and other European RLS association.', 'detailedDescription': 'In this study, the investigators want to study the clinical course of RLS in a population of RLS patients who are members of the RLS patient association, taking into account clinical and biological factors as well as the treatments taken for RLS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with RLS who are members of the RLS patient association', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Adults subjects\n* Restless legs syndrome diagnosis\n* Member of the restless legs syndrome association\n* French speaking\n* Able to understand the study\n* Signed written informed consent\n* Affiliated to social security\n\nExclusion criteria:\n\n\\- Vulnerable subject : subject deprived of liberty or protected by law (trusteeship, legal guardianship)'}, 'identificationModule': {'nctId': 'NCT05044520', 'acronym': 'Clin-RLS', 'briefTitle': 'Clinical Features Associated With Restless Legs Syndrome.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Clinical Features Associated With Restless Legs Syndrome : Clin-RLS', 'orgStudyIdInfo': {'id': 'RECHMPL21_0535'}}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sofiene Chenini, MD', 'role': 'CONTACT', 'email': 'sofienechenini@hotmail.com', 'phone': '467332237', 'phoneExt': '33'}, {'name': 'Yves DAUVILLIERS, MD PhD', 'role': 'CONTACT', 'email': 'y-dauvilliers@chu-montpellier.fr', 'phone': '467337478', 'phoneExt': '33'}], 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'centralContacts': [{'name': 'Sofiene Chenini, MD', 'role': 'CONTACT', 'email': 'sofienechenini@hotmail.com', 'phone': '467332237', 'phoneExt': '33'}, {'name': 'Yves DAUVILLIERS, MD PhD', 'role': 'CONTACT', 'email': 'y-dauvilliers@chu-montpellier.fr', 'phone': '467337478', 'phoneExt': '33'}], 'overallOfficials': [{'name': 'Yves DAUVILLIERS, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}