[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571877":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":80,"collaborators":83,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":25,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":25,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":109,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"Hospital Clinico Universitario de Santiago","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional Epley maneuver","ACTIVE_COMPARATOR","Participants will be advised to perform Brandt-Daroff exercises at home twice daily for 8 weeks. An MRI of the inner ear and posterior cranial fossa will also be requested. If the exercises are ineffective, repositioning maneuvers using a mechanized chair will be repeated biweekly until symptom resolution.",[13],"Procedure: Conventional Epley maneuver",{"label":15,"type":16,"description":17,"interventionNames":18},"Personalized Epley maneuver","EXPERIMENTAL","Participants will perform Brandt-Daroff exercises at home twice daily for 8 weeks. An MRI will be conducted, and based on the images, a personalized mathematical model will be created to modify the angles of the repositioning maneuver. If the exercises are ineffective, the personalized maneuver will be performed using a mechanized chair.",[19],"Procedure: Personalized Epley maneuver",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Epley maneuver using a mechanized chair",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Personalized Epley maneuver, using a mechanized chair",[15],[30],{"name":31,"affiliation":32,"role":33},"Andrés Soto-Varela, Prof, PhD","Complexo Hospitalario Universitario de Santiago","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":25,"email":38},"CONTACT","+34981951157","andres.soto.varela@sergas.es",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"Ismael Arán-Tapia, PhD","+34663654574","ismaelaran.tapia@usc.es",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Hospital Clínico Universitario","RECRUITING","Santiago de Compostela","A Coruña","15706","Spain","ES",{"type":53,"coordinates":54},"Point",[55,56],-8.54569,42.88052,{"lat":56,"lon":55},[59,61,64,66,68,70,72,74,76,78],{"name":60,"role":36,"phone":37,"phoneExt":25,"email":38},"Andrés Soto-Varela, PhD",{"name":62,"role":63,"phone":25,"phoneExt":25,"email":25},"Miguel Blanco-Ulla","SUB_INVESTIGATOR",{"name":65,"role":63,"phone":25,"phoneExt":25,"email":25},"Sofía Santos-Pérez",{"name":67,"role":63,"phone":25,"phoneExt":25,"email":25},"Marcos Rossi-Izquierdo",{"name":69,"role":63,"phone":25,"phoneExt":25,"email":25},"Ismael Arán-González",{"name":71,"role":63,"phone":25,"phoneExt":25,"email":25},"Isabel Vaamonde-Sánchez-Andrade",{"name":73,"role":63,"phone":25,"phoneExt":25,"email":25},"Virginia Franco-Gutiérrez",{"name":75,"role":63,"phone":25,"phoneExt":25,"email":25},"Vicente Pérez-Muñuzuri",{"name":77,"role":63,"phone":25,"phoneExt":25,"email":25},"Alberto Pérez-Muñuzuri",{"name":79,"role":63,"phone":25,"phoneExt":25,"email":25},"Ismael Arán-Tapia",{"type":33,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Andrés Soto-Varela","Professor and Chairman",[84,87],{"name":85,"class":86},"Instituto de Salud Carlos III","OTHER_GOV",{"name":88,"class":6},"European Union","100571877","personalized-treatment-of-refractory-bppv-100571877",false,"NCT06725966","Personalized Treatment of Refractory BPPV","Personalized Medicine to Treat Refractory Benign Paroxysmal Positional Vertigo, Through Computational Fluid Dynamics Analysis From Magnetic Resonance Image Reconstructions","Inclusion Criteria:\n\n* A. Diagnosed with BPPVp according to the Barany Society criteria:\n\n  1. Recurrent episodes of vertigo or positional instability, triggered by lying down or turning the head in the supine position.\n  2. Episodes lasting less than 1 minute.\n  3. Positional nystagmus observed after a latency period during the Dix-Hallpike test (DHT), with an upward vertical component and a torsional component (clockwise on the left side and counterclockwise on the right).\n  4. Symptoms not explained by any other cause.\n\n     AND\n* B. Refractory to otolith repositioning maneuvers (Epley and\u002For Semont maneuvers), with persistence of symptoms after three attempts.\n\nExclusion Criteria:\n\n* Cognitive impairment that prevents understanding of their condition and the required procedures.\n* Pathological conditions that hinder the execution of the maneuvers.\n* BPPV involving canals other than the posterior canal or bilateral posterior canal involvement.\n* Low educational level, which may impede understanding of the procedures and informed consent.","ALL","18 Years","100 Years",{"count":100,"type":101},54,"ESTIMATED","INTERVENTIONAL",[104],"NA","Background: Benign paroxysmal positional vertigo (BPPV) is the most common cause of vertigo, often effectively treated with standard canalith repositioning maneuvers (CRMs). However, approximately 12.5% of cases remain refractory, leading to persistent symptoms and increased healthcare burden. Variations in the anatomical orientation of the semicircular canals (SCCs) may explain the resistance to conventional maneuvers. This study explores a personalized medicine approach, utilizing computational fluid dynamics (CFD) based on MRI reconstructions to tailor CRMs with the help of mechanical rotation chair according to individual inner ear anatomy.\n\nMethods: The investigators conducted a randomized, multicenter, open-label study targeting patients with refractory posterior canal BPPV. Participants were allocated to either a control group (receiving repeated standard CRMs and Brandt-Daroff exercises) or an intervention group (receiving personalized CRMs based on CFD simulations derived from MRI scans). The intervention group's maneuvers were executed using a mechanical rotational chair designed for precise angulation. Primary outcomes included resolution of nystagmus and vertigo symptoms, while secondary outcomes measured the reduction in healthcare visits and improved quality of life (Dizziness Handicap Inventory score).",[107,108],"Benign Paroxysmal Positional Vertigo","Personalized Medicine",[110,111,112,113,114,115],"BPPV","Benign paroxysmal positional vertigo","Computational fluid dynamics","MRI","Canalith repositioning maneuvers","Mechanical rotation chair","2024-12-08",{"date":118,"type":119},"2024-12-10","ACTUAL",{"date":121,"type":119},"2024-07-01",{"date":123,"type":101},"2026-12-31",{"name":5,"class":6},1]