Ignite Creation Date:
2025-12-24 @ 12:45 PM
Ignite Modification Date:
2025-12-28 @ 1:30 AM
Study NCT ID:
NCT04553861
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2020-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smartwatch ABPM vs. Conventional ABPM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D018660', 'term': 'Blood Pressure Monitoring, Ambulatory'}], 'ancestors': [{'id': 'D001795', 'term': 'Blood Pressure Determination'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D018670', 'term': 'Monitoring, Ambulatory'}, {'id': 'D008991', 'term': 'Monitoring, Physiologic'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'targetDuration': '2 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-05', 'studyFirstSubmitDate': '2020-09-11', 'studyFirstSubmitQcDate': '2020-09-11', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean nighttime blood pressure', 'timeFrame': 'Baseline', 'description': 'Correlation of mean nighttime BP between the ABPM and the BP using the smartwatch'}], 'secondaryOutcomes': [{'measure': 'Every time point blood pressure', 'timeFrame': 'Baseline', 'description': 'BP differences between the ABPM and the BP using the smartwatch at every time point of measurement'}, {'measure': 'Mean 24-hour blood pressure', 'timeFrame': 'Baseline', 'description': 'Correlation of mean 24-h BP between the ABPM and the BP using the smartwatch'}, {'measure': 'Mean daytime blood pressure', 'timeFrame': 'Baseline', 'description': 'Correlation of mean daytime BP between the ABPM and the BP using the smartwatch'}, {'measure': 'Nighttime dipping', 'timeFrame': 'Baseline', 'description': 'Correlation of nighttime dipping between the ABPM and the BP using the smartwatch'}, {'measure': 'Morning blood pressure', 'timeFrame': 'Baseline', 'description': 'Correlation of morning BP between the ABPM and the BP using the smartwatch'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Blood Pressure', 'Ambulatory blood pressure monitoring', 'Smartwatch'], 'conditions': ['Blood Pressure']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate the accuracy and precision of the Samsung Smartwatch with conventional ambulatory blood pressure monitoring in healthy volunteers.', 'detailedDescription': "Blood pressure (BP) monitoring outside of the medical care environment is an increasingly important part of clinical hypertension assessment and management. Ambulatory BP monitoring (ABPM) uses automatic detection and recording devices for repeated determinations during an extended period, typically 24 hours. This technique has been shown to substantially enhance the clinician's understanding of BP behavior in patients and aid in diagnosis and therapeutic decision making. The ABPM is superior to office BP in predicting target organ, hypertensive cerebrovascular disease, retinopathy, renal abnormalities, and alterations in vascular compliance.1-4) Most of these studies have also demonstrated that a loss of nocturnal decline in BP (so-called non-dipper) conveys excessive risk for stroke and myocardial infarction.\n\nAlthough conventional ABMP is usually well tolerated by patients, a few problems do exist. A minority of patients do not sleep well with the recorders and tend to have somewhat higher BP values. Cuffs can also rotate, and different arm positions can change BP significantly. Rarely, patients may develop erythema, ecchymoses, petechiae, or superficial phlebitis in the area distal to cuff placement.\n\nRecently, smartwatches that measure BP without a cuff have become available. Since these measurements are relatively more user-friendly than conventional cuff-based measurements, they may aid in more frequent BP monitoring. Currently, only one study compared a non-commercial armband wearable pulse transit time (PTT) system for 24-hour cuff-less BP measurement with ABPM.5) We will investigate the accuracy and precision of Samsung Smartwatch with ABPM in young, healthy volunteers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy subjects willing to participate in this trial', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n* Ambulatory healthy subjects\n* Subjects aged 20 years or more\n* Subjects willing to participate in this study voluntarily Exclusion criteria\n* Subjects inability to provide informed consent\n* Subjects with any medical history\n* Subjects with irregular heart rhythm (e.g. atrial fibrillation, atrial flutter, or bigeminy)\n* Subjects unable to wear a watch due to wrist circumference\n* Subjects with BP difference 10mmHg or more between left and right arm'}, 'identificationModule': {'nctId': 'NCT04553861', 'acronym': 'SamsungWatch', 'briefTitle': 'Smartwatch ABPM vs. Conventional ABPM', 'organization': {'class': 'OTHER', 'fullName': 'Wonju Severance Christian Hospital'}, 'officialTitle': 'Correlation Between Smartwatch-based Blood Pressure Monitoring and Conventional Ambulatory Blood Pressure Monitoring', 'orgStudyIdInfo': {'id': 'SamsungWatch'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy subjects', 'description': 'Healthy subjects without blood pressure difference on both arm', 'interventionNames': ['Device: Ambulatory blood pressure monitoring', 'Device: Galaxy Watch Active2']}], 'interventions': [{'name': 'Ambulatory blood pressure monitoring', 'type': 'DEVICE', 'description': 'Every 30 minutes from 7 AM to 10 PM and every 1 hour from 10 PM to 7 AM', 'armGroupLabels': ['Healthy subjects']}, {'name': 'Galaxy Watch Active2', 'type': 'DEVICE', 'description': 'Every 1 hour by subject (on-demand) from 7 AM to 10 PM and every 5 minutes (automatic) from 10 PM to 7 AM', 'armGroupLabels': ['Healthy subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26426', 'city': 'Wŏnju', 'state': 'Gangwon-do', 'country': 'South Korea', 'facility': 'Wonju Severance Christian Hospital', 'geoPoint': {'lat': 37.35139, 'lon': 127.94528}}], 'overallOfficials': [{'name': 'Young Jin Youn, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wonju Severance Christian Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wonju Severance Christian Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Samsung Electronics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Division of Cardiology, Department of Internal Medicine', 'investigatorFullName': 'Young Jin Youn', 'investigatorAffiliation': 'Wonju Severance Christian Hospital'}}}}