[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633175":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":59,"collaborators":61,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Aktiia SA","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Aktiia G1 BP monitor (or \"Hilo\") - intervention","EXPERIMENTAL","These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period.",[13],"Device: Aktiia G1 BP monitor for 12 months",{"label":15,"type":16,"description":17,"interventionNames":18},"Group 2: Traditional BP monitor (upper arm cuff) - active control","ACTIVE_COMPARATOR","These participants will receive a traditional BP monitor (validated upper arm cuff) to use for the 6 months comparison period. At the 6-month visit, they will return the traditional BP monitor and receive an Aktiia G1 BP monitor for the 6-month follow-up period.",[19],"Device: Traditional BP monitor for 6 months \u002F Aktiia G1 BP monitor for 6 months",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DEVICE","Aktiia G1 BP monitor for 12 months",[9],null,{"type":22,"name":27,"description":17,"armGroupLabels":28,"otherNames":25},"Traditional BP monitor for 6 months \u002F Aktiia G1 BP monitor for 6 months",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Kristen Harriott","CONTACT","617-525-8493","BWHWearableBP@mgb.org",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Mass General Brigham Hospital","RECRUITING","Boston","Massachusetts","02115","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-71.05977,42.35843,{"lat":48,"lon":47},[51,52,55,57],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"name":53,"role":54,"phone":25,"phoneExt":25,"email":25},"Dr. Naomi Fisher, MD","SUB_INVESTIGATOR",{"name":56,"role":54,"phone":25,"phoneExt":25,"email":25},"Dr. Ezgi Guzelce, MD",{"name":58,"role":54,"phone":25,"phoneExt":25,"email":25},"Dr. Ozan Unlu, MD",{"type":60,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[62,65],{"name":63,"class":64},"Massachusetts General Hospital","OTHER",{"name":66,"class":64},"Brigham and Women's Hospital","100633175","wearable-bp-wearable-everyday-automated-readings-to-enable-assessment-of-blood-pressure-control-100633175",false,"NCT07523269","WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure Control","WEARABLE-BP","Inclusion Criteria:\n\n* Adults aged 21 to 85 years.\n* Able to read and speak English.\n* Have an MGB provider and medical record number in EPIC\n* Study participants will wear the Aktiia bracelet for 6 months\n* Willing to attend two on-site study visits and comply with all study procedures.\n* Signed informed consent provided.\n* Own a smartphone with iOS or Android operating system.\n* Hypertensive with uncontrolled systolic blood pressure (SBP) \\>135 mm Hg by unattended automated office measurement\n* Currently taking 0, 1 or 2 antihypertensive medications.\n\nExclusion Criteria:\n\n* Severe hypertension (SBP \\> 180 mmHg or DBP \\> 120 mmHg).\n* Pregnant or breastfeeding.\n* Known severe heart failure (LVEF \\\u003C 35%).\n* Known severe valvular heart disease.\n* Known pheochromocytoma.\n* Known severe chronic kidney disease (CKD stage 4-5; eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²).\n* Known uncontrolled hyperthyroidism or hypothyroidism.\n* Known severe diabetes (Hemoglobin A1c \\> 10%).\n* Known resting heart rate \\> 120 bpm.\n* Known persistent atrial fibrillation.\n* Known Raynaud's disease.\n* Known tremors or shivering disorders.\n* Known exfoliative skin diseases.\n* Known allergy to silicone.\n* Presence of lymphedema.\n* Paralysis of the arm.\n* Arm amputation.\n* Presence of implanted devices, such as a pacemaker, defibrillator, intravascular device, or arteriovenous fistula.\n* Upper arm circumference \\\u003C 22 cm or \\> 42 cm.\n* Wrist circumference \\> 23 cm.\n* Mastectomy","ALL","21 Years","85 Years",{"count":78,"type":79},164,"ESTIMATED","INTERVENTIONAL",[82],"NA","The WEARABLE-BP study will evaluate the clinical value of obtaining continual measurements using the Aktiia G1 Optical Blood Pressure Monitoring (OBPM) device in hypertensive patients, compared to using a traditional upper arm cuff for home BP monitoring.\n\nThe WEARABLE-BP study aims to compare the change in unattended automated office blood pressure from baseline to 6 months between two study groups: those given an Aktiia G1 BP monitor and those given a traditional upper arm BP cuff.",[85],"Hypertension (HTN)",[87,88,89],"Vascular Diseases","Cardiovascular Diseases","Hypertension","2026-04-08",{"date":92,"type":93},"2026-04-13","ACTUAL",{"date":95,"type":79},"2026-04",{"date":97,"type":79},"2027-12",{"name":5,"class":6},1]