[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611457":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":34,"responsibleParty":200,"collaborators":202,"id":205,"slug":206,"hasResults":207,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":207,"sex":213,"minAge":214,"maxAge":32,"enrollmentInfo":215,"targetDuration":32,"studyType":218,"phases":219,"briefSummary":221,"conditions":222,"keywords":227,"overallStatus":37,"whyStopped":32,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":243},{"fullName":5,"class":6},"Biobeat Technologies Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Device: Non-invasive monitoring","EXPERIMENTAL","The study is designed as a prospective, multicenter, single arm, validation study that follows the 2023 European Society of Hypertension (ESH) recommendations for the validation of cuffless blood pressure measuring devices.27 There is no primary hypothesis. The study will validate 24-hours blood pressure monitoring using the investigational FDA-cleared device by comparing the level of agreement with parallel measurements obtained by the gold-standard upper arm. The Awake\u002FAsleep test is the first and primary test recommended for this type of device to assess validity.",[13],"Device: Model BB-613WP",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Model BB-613WP","During the study period, participants will undergo standard ABPM monitoring per clinical indication and wear a PPG-based monitor",[9],[21],"Biobeat Chest-Patch, PPg-based monitor",[23],{"name":24,"affiliation":25,"role":26},"Ziad Zoghby, M.D., M.B.A.","Mayo Clinic College of Medicine","PRINCIPAL_INVESTIGATOR",[28],{"name":29,"role":30,"phone":31,"phoneExt":32,"email":33},"Ruth Caspi-Molad, M.S.c","CONTACT","+972546969474",null,"ruthie.caspi@bio-beat.com",[35,56,77,92,111,130,146,160,173,186],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Cardiology, P.C.","RECRUITING","Birmingham","Alabama","35211","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-86.80249,33.52066,{"lat":47,"lon":46},[50,54],{"name":51,"role":30,"phone":52,"phoneExt":32,"email":53},"Susan DeRamus, Clinical Research Director, RN, CCRC","205-949-5275","sderamus@cardiologypc.com",{"name":55,"role":26,"phone":32,"phoneExt":32,"email":32},"Ferrell O. Mendelsohn, MD",{"facility":57,"status":37,"city":58,"state":59,"zip":60,"country":41,"countryCode":42,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Mayo Clinic","Scottsdale","Arizona","85259",{"type":44,"coordinates":62},[63,64],-111.89903,33.50921,{"lat":64,"lon":63},[67,71,75],{"name":68,"role":30,"phone":69,"phoneExt":32,"email":70},"Betty Monari, Associate Clinical Research Coordinator","480-574-2641","Monari.Betty@mayo.edu",{"name":72,"role":30,"phone":73,"phoneExt":32,"email":74},"Desiree N. Osborne, Associate Clinical Research Coordinator","480-574-2234","osborne.desiree@mayo.edu",{"name":76,"role":26,"phone":32,"phoneExt":32,"email":32},"Sayeed Khalillullah, MD",{"facility":57,"status":37,"city":78,"state":79,"zip":80,"country":41,"countryCode":42,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Jacksonville","Florida","32224",{"type":44,"coordinates":82},[83,84],-81.65565,30.33218,{"lat":84,"lon":83},[87,90],{"name":88,"role":30,"phone":32,"phoneExt":32,"email":89},"Umar Farooq, ACRC","farooq.muhammad@mayo.edu",{"name":91,"role":26,"phone":32,"phoneExt":32,"email":32},"Lyle W. Baker, MD",{"facility":93,"status":37,"city":94,"state":79,"zip":95,"country":41,"countryCode":42,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"U Health-University of Miami Health System","Miami","33136",{"type":44,"coordinates":97},[98,99],-80.19366,25.77427,{"lat":99,"lon":98},[102,106,109],{"name":103,"role":30,"phone":104,"phoneExt":32,"email":105},"Bonni Lang, RN, BSN, MS, MBA","305-243-4950","blang@med.miami.edu",{"name":107,"role":30,"phone":32,"phoneExt":32,"email":108},"Claudine Berthold","cxb1646@med.miami.edu",{"name":110,"role":26,"phone":32,"phoneExt":32,"email":32},"Maria Delgado, MD",{"facility":57,"status":37,"city":112,"state":113,"zip":114,"country":41,"countryCode":42,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Rochester","Minnesota","55905",{"type":44,"coordinates":116},[117,118],-92.4699,44.02163,{"lat":118,"lon":117},[121,125,128],{"name":122,"role":30,"phone":123,"phoneExt":32,"email":124},"Travis Nusbaum, Study Coordinator","507-538-6379","nusbaum.travis@mayo.edu",{"name":126,"role":30,"phone":32,"phoneExt":32,"email":127},"Justin Webster, Associate Clinical Research Coordinator, B. S","Webster.Justin@mayo.edu",{"name":129,"role":26,"phone":32,"phoneExt":32,"email":32},"Ziad Zoghby, MD, MBA",{"facility":131,"status":37,"city":132,"state":32,"zip":133,"country":134,"countryCode":135,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"HaEmek Hospital","Afula","1834111","Israel","IL",{"type":44,"coordinates":137},[138,139],35.2892,32.60907,{"lat":139,"lon":138},[142,144],{"name":143,"role":30,"phone":32,"phoneExt":32,"email":32},"Kerstin Carlin Ram, Research Coordinator",{"name":145,"role":26,"phone":32,"phoneExt":32,"email":32},"Lee Goldsetin Goldsetin, MD",{"facility":147,"status":37,"city":148,"state":32,"zip":149,"country":134,"countryCode":135,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"The Holy Family Hospital Nazareth","Nazareth","1641100",{"type":44,"coordinates":151},[152,153],35.29719,32.70087,{"lat":153,"lon":152},[156,158],{"name":157,"role":30,"phone":32,"phoneExt":32,"email":32},"Diala Najjar, Research Coordinator",{"name":159,"role":26,"phone":32,"phoneExt":32,"email":32},"Nayef Habashi, MD",{"facility":161,"status":37,"city":162,"state":32,"zip":32,"country":134,"countryCode":135,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Sheba Medical Center","Ramat Gan",{"type":44,"coordinates":164},[165,166],34.81065,32.08227,{"lat":166,"lon":165},[169,171],{"name":170,"role":30,"phone":32,"phoneExt":32,"email":32},"Irena Tahel Cahana, Research Coordinator",{"name":172,"role":26,"phone":32,"phoneExt":32,"email":32},"Pazit Beckerman, MD",{"facility":174,"status":37,"city":175,"state":32,"zip":32,"country":134,"countryCode":135,"cosmosGeoPoint":176,"geoPoint":180,"contacts":181},"Maccabi Healthcare","Tel Aviv",{"type":44,"coordinates":177},[178,179],34.78057,32.08088,{"lat":179,"lon":178},[182,184],{"name":183,"role":30,"phone":32,"phoneExt":32,"email":32},"Ella Goldberg, Research Coordinator",{"name":185,"role":26,"phone":32,"phoneExt":32,"email":32},"Galit Perez",{"facility":187,"status":188,"city":189,"state":32,"zip":32,"country":190,"countryCode":191,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Instituto Auxologico Italiano","NOT_YET_RECRUITING","Milan","Italy","IT",{"type":44,"coordinates":193},[194,195],12.59836,42.78235,{"lat":195,"lon":194},[198],{"name":199,"role":26,"phone":32,"phoneExt":32,"email":32},"Prof. Gianfranco Parati Parati, MD",{"type":201,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[203],{"name":57,"class":204},"OTHER","100611457","accuracy-of-a-cuffless-photoplethysmography-ppg-chest-patch-monitor-for-24-hour-ambulatory-blood-pressure-monitoring-abpm-100611457",false,"NCT07240831","Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring (ABPM)","Accuracy of a Cuffless Photoplethysmography (PPG) Chest-Patch Monitor for 24-hour Ambulatory Blood Pressure Monitoring","PPG ABPM","Inclusion Criteria\n\n* Females and Males subjects 18 years or older (from all skin tones\u002Fcolors)\n* Scheduled for ABPM for hypertension screening, evaluation, or management\n* Subjects capable of using an application temporarily downloaded (for the duration of the study) on a personal smart phone device or on a device provided by the study sponsor\n* Subjects with Atrial fibrillation or Atrial flutter are eligible to participate if standard cuff-based ABPM monitor can capture blood pressure at initialization\n\nExclusion Criteria\n\n* Indication for ABPM is orthostatic hypotension or Postural Orthostatic Tachycardiac Syndrome as indicated on the ABPM referral order\n* Any neurological, psychological, or other condition impairing the ability to provide informed consent or participate in the study\n* Inability to reliably access the Internet via a smart phone\n* Not able to perform standard cuff-based ABPM\n* Average absolute difference between the two arms is greater than 15 mmHg for Systolic Blood Pressure (SBP) or greater than 10 mmHg Diastolic Blood Pressure (DBP) during the initialization\u002Fcalibration phase\n* Subjects with known allergy to adhesives or skin patches\n* Subjects with solid dark tattoos on the area where the PPG-based device is attached\n* Subjects who are unwilling to have their chest hair shaved, if needed, to install the device (the device uses adhesives and needs to be in direct contact with the skin without hair)\n* Subjects who are unwilling to comply with the study instructions (avoid vigorous exercise and showering for 24 hours while the device is in place)","ALL","18 Years",{"count":216,"type":217},600,"ESTIMATED","INTERVENTIONAL",[220],"NA","This study aims to validate the accuracy and reliability of blood pressure (BP) estimates obtained over 24 hours using a PPG-based chest-patch device compared to the gold standard ambulatory blood pressure monitoring (ABPM) method using an upper arm cuff-based oscillometric BP device, in both hypertensive and normotensive individuals referred by their provider to undergo a 24-hours ABPM for clinical indication. The Awake\u002FAsleep test, which is the primary test recommended for automated wearable cuffless BP devices that are cuff-calibrated (based on the 2023 European Society of Hypertension (ESH) recommendations for the validation of cuffless blood pressure measuring devices), will be conducted in this study. The secondary aim of the study is to assess the feasibility and convenience of the PPG-based device.",[223,224,225,226],"Blood Pressure","Heart Disease","Hypertension (HTN)","Blood Pressure Monitoring",[228,229,225,230,231,232,233],"BLOOD PRESSURE","BLOOD PRESSURE MONITORING","CUFFLESS PHOTOPLETHYSMOGRAPHY","PPG","CUFFLESS","vital signs","2026-06-01",{"date":236,"type":237},"2026-06-02","ACTUAL",{"date":239,"type":237},"2025-12-15",{"date":241,"type":217},"2026-10-30",{"name":5,"class":6},10]