[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557892":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":53,"locations":64,"responsibleParty":150,"collaborators":30,"id":152,"slug":153,"hasResults":154,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":160,"sex":161,"minAge":162,"maxAge":30,"enrollmentInfo":163,"targetDuration":30,"studyType":166,"phases":167,"briefSummary":169,"conditions":170,"keywords":175,"overallStatus":67,"whyStopped":30,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":185,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},{"fullName":5,"class":6},"Hospices Civils de Lyon","OTHER",[8,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with cryopyrin-associated periodic syndrome (CAPS)","ACTIVE_COMPARATOR","Confirmed by genetic analysis of NLRP3",[13,14,15,16,17,18],"Genetic: Genetic analysis of NLRP3","Device: Circadian rhythm measurement","Biological: Saliva sampling","Other: Questionnaire","Other: AIDAI score","Biological: Blood sampling",{"label":20,"type":21,"description":22,"interventionNames":23},"Control group","PLACEBO_COMPARATOR","Healthy participant (absence of CAPS, verified by NLRP3 gene analysis) living in the same household as a CAPS participant included in the protocol",[13,14,15,16,18],[25,31,36,41,45,49],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"GENETIC","Genetic analysis of NLRP3","Blood test for genetic analysis of NLRP3",[20,9],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"DEVICE","Circadian rhythm measurement","Wear a Withings Pulse HR (heart rate) actigraphic watch 24 hours a day for 1 month to define circadian rhythm",[20,9],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":30},"BIOLOGICAL","Saliva sampling","Saliva sampling for salivary melatonin determination",[20,9],{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":30},"Questionnaire","Questionnaire to determine chronotype",[20,9],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":30},"AIDAI score","Disease activity score using AIDAI score (only for patients in the CAPS group) AIDAI : AUTO-INFLAMMATORY DISEASE ACTIVITY INDEX",[9],{"type":37,"name":50,"description":51,"armGroupLabels":52,"otherNames":30},"Blood sampling","1. Inflammatory cytokines measurement : IL1-beta (Interleukin-1) and IL-18.\n2. Molecular characterization of circadian clock signaling pathways",[20,9],[54,60],{"name":55,"role":56,"phone":57,"phoneExt":58,"email":59},"Alexandre Alexandre, PR","CONTACT","04 27 85 61 26","33","Alexandre.belot@chu-lyon.fr",{"name":61,"role":56,"phone":62,"phoneExt":58,"email":63},"Samira Plassart","04 27 85 54 42","Samira.plassart@chu-lyon.fr",[65,83,98,112,123,138],{"facility":66,"status":67,"city":68,"state":30,"zip":69,"country":70,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Hôpital Femme-Mère-Enfant (HCL)","RECRUITING","Bron","69677","France","FR",{"type":73,"coordinates":74},"Point",[75,76],4.91303,45.73865,{"lat":76,"lon":75},[79,81],{"name":80,"role":56,"phone":57,"phoneExt":58,"email":59},"Alexandre Belot, MD;PhD",{"name":80,"role":82,"phone":30,"phoneExt":30,"email":30},"PRINCIPAL_INVESTIGATOR",{"facility":84,"status":85,"city":86,"state":30,"zip":87,"country":70,"countryCode":71,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Hôpital Claude Huriez (CHU de Lille)","NOT_YET_RECRUITING","Lille","59037",{"type":73,"coordinates":89},[90,91],3.05512,50.63391,{"lat":91,"lon":90},[94,97],{"name":95,"role":56,"phone":30,"phoneExt":30,"email":96},"Éric HACHULLA, MD;PhD","eric.hachulla@chru-lille.fr",{"name":95,"role":82,"phone":30,"phoneExt":30,"email":30},{"facility":99,"status":85,"city":100,"state":30,"zip":101,"country":70,"countryCode":71,"cosmosGeoPoint":102,"geoPoint":106,"contacts":107},"Hôpital de la Croix-Rousse (HCL)","Lyon","69004",{"type":73,"coordinates":103},[104,105],4.84789,45.74906,{"lat":105,"lon":104},[108,111],{"name":109,"role":56,"phone":30,"phoneExt":30,"email":110},"Yvan Jamilloux, MD;PhD","yvan.jamilloux@chu-lyon.fr",{"name":109,"role":82,"phone":30,"phoneExt":30,"email":30},{"facility":113,"status":85,"city":100,"state":30,"zip":114,"country":70,"countryCode":71,"cosmosGeoPoint":115,"geoPoint":117,"contacts":118},"Hôpital Edouard Herriot (HCL)","69437",{"type":73,"coordinates":116},[104,105],{"lat":105,"lon":104},[119,122],{"name":120,"role":56,"phone":30,"phoneExt":30,"email":121},"Thomas Barba, MD","thomas.barba@chu-lyon.fr",{"name":120,"role":82,"phone":30,"phoneExt":30,"email":30},{"facility":124,"status":85,"city":125,"state":30,"zip":126,"country":70,"countryCode":71,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Hôpital Tenon (AP-HP)","Paris","75020",{"type":73,"coordinates":128},[129,130],2.3488,48.85341,{"lat":130,"lon":129},[133,137],{"name":134,"role":56,"phone":135,"phoneExt":58,"email":136},"Sophie Georgin-Lavialle, MD;PhD","01 56 01 60 77","sophie.georgin-lavialle@aphp.fr",{"name":134,"role":82,"phone":30,"phoneExt":30,"email":30},{"facility":139,"status":85,"city":125,"state":30,"zip":140,"country":70,"countryCode":71,"cosmosGeoPoint":141,"geoPoint":143,"contacts":144},"Hôpital Kremlin-Bicêtre (AP-HP)","94270",{"type":73,"coordinates":142},[129,130],{"lat":130,"lon":129},[145,149],{"name":146,"role":56,"phone":147,"phoneExt":30,"email":148},"Isabelle Koné-Paut, MD;PhD","01 45 21 32 46","isabelle.kone-paut@aphp.fr",{"name":146,"role":82,"phone":30,"phoneExt":30,"email":30},{"type":151,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100557892","circadian-rhythm-deregulation-in-patients-with-caps-100557892",false,"NCT06544018","Circadian Rhythm Deregulation in Patients With CAPS","Identification of Circadian Rhythm Deregulation in Patients With Cryopyrin-associated Periodic Syndrome (CAPS)","ICARUS","---Inclusion Criteria:\n\nPatient with CAPS group :\n\n* Patients aged 6 and over\n* Participant with CAPS confirmed by NLRP3 genetic analysis\n* Weight greater than or equal to 25 Kg\n* Parents\u002Fguardians who have been informed of the study and have signed a consent form.\n* Patient affiliated to a social security scheme\n\nControl group (healthy participant):\n\n* Participant aged 6 and over\n* Weight greater than or equal to 25 Kg\n* Participant living in the same household as a subject with CAPS genetically confirmed by NLRP3 analysis and included in the protocol\n* Participant with no CAPS (a priori) who consents to NLRP3 genetic analysis\n* Parents\u002Fguardians who have been informed of the study and have signed a consent form.\n* Participant who has been informed of the study and has agreed to take part\n* Participant affiliated to a social security scheme\n\n  * Exclusion Criteria :\n\nPatient with CAPS group :\n\n* Patients with chronic sleep disorders (narcolepsy, hypersomnia) requiring medication (sleeping pills, melatonin).\n* Patients with sleep apnea syndrome\n* Patients working regular night shifts or alternating day and night shifts\n* Pregnant or breast-feeding women\n* Parents with an infant under 6 months of age\n* Patient participating in another interventional drug study\n* Deprivation of civil rights (curators, guardianship, safeguard of justice)\n\nControl group (healthy participant):\n\n* Participants with a chronic illness (ALD beneficiaries)\n* Participants with chronic sleep disorders (narcolepsy, hypersomnia) requiring medication (sleeping pills, melatonin)\n* Participants working regular night shifts or alternating day and night shifts\n* Pregnant or breast-feeding women\n* Parents with an infant under 6 months of age\n* Participant participating in another interventional drug study\n* Deprivation of civil rights (curators, guardianship, safeguard of justice)",true,"ALL","6 Years",{"count":164,"type":165},30,"ESTIMATED","INTERVENTIONAL",[168],"NA","Circadian rhythms are characterized by the physiology's adaptation to the alternation of day and night, enabling to adapt to the environment. These rhythms are generated by a molecular clock within each cell. At the molecular level, the circadian clock is based on a complex system of cell-autonomous transcription loops. These exert positive and negative feedback on themselves, generating cyclic transcriptional activity.\n\n* In the main loop, the BMAL1 transcription factor links with CLOCK or NPAS2 ( (Neuronal PAS Domain Protein 2) to activate transcription of per1,2 and 3 and cryptochrome (cry1 and cry2), which in turn repress BMAL1\u002FCLOCK1 transcriptional activity.. The BMAL1\u002FCLOCK complex also activates transcription of numerous target genes (per and cry, Rev-erb, etc.)..\n* other secondary loops refine the function of the first.\n\nRecent studies suggest that many aspects of innate immunity are controlled by circadian rhythm through inhibition of NLRP3 inflammasome activation. Nevertheless, the regulation of the NLRP3 inflammasome by the circadian clock has yet to be elucidated. Inflammasomes are molecular platforms that control caspase-1 activation and consequently the maturation of precursors of (interleukine) IL-1β, pro-IL-18, a pro-inflammatory cytokine. Since its discovery, its functions have been widely characterized as part of the innate immune response as a sensor of pathogens and danger signals (extracellular ATP (Adenosine triphosphate), atmospheric pollutants). NLRP3 (nucleotide-binding domain LRR (leucin-rich repeat ) and pyrin-containing receptor 3) has been described for its genetic association with dominant monogenic hereditary syndromes characterized by recurrent systemic inflammatory episodes in the absence of any infection or autoimmune disease, known as CAPS (cryopyrin-associated periodic syndrome) or cryopyrinopathies which is a continuum of diseases ranging from a moderate to the most severe form of the syndrome: familial cold urticaria syndrome, Muckle-Wells syndrome (MWS), and CINCA\u002FNOMID syndrome.\n\nInterestingly, patients with Muckle-Wells syndrome show a circadian pattern of symptoms, with a recurrent, predominantly vesperal fever peak lasting a few hours, and extreme fatigue on a daily basis. However, a molecular link between the circadian clock and CAPS pathology remains to be determined.\n\nThe aim of this protocol is to identify circadian rhythm dysregulation in patients with CAPS confirmed by genetic analysis of NLRP3, to demonstrate a link between circadian clock and CAPS syndrome, and to identify circadian clock regulatory pathways.",[171,172,173,174],"Cryopyrin Associated Periodic Syndrome","Familial Cold Urticaria","Muckle-Wells Syndrome","CINCA Syndrome",[176,177,178,179,180],"Circadian clock","cryopyrin-associated periodic syndrome","familial cold urticaria","muckle-wells syndrome","melatonin","2026-02-25",{"date":183,"type":184},"2026-02-27","ACTUAL",{"date":181,"type":184},{"date":187,"type":165},"2029-02-25",{"name":5,"class":6},6]