Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-28 @ 11:41 PM
Study NCT ID:
NCT05302193
Status:
COMPLETED
Last Update Posted:
2025-03-25
First Post:
2022-03-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Blood Pressure Measurement Using Samsung Smartwatch
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006339', 'term': 'Heart Rate'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D055986', 'term': 'Vital Signs'}, {'id': 'D010808', 'term': 'Physical Examination'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006439', 'term': 'Hemodynamics'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Two measuring devices are active simultaneously during measurement of blood pressure and heart rate on each participant and their functioning is compared.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2022-03-16', 'studyFirstSubmitQcDate': '2022-03-29', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Similarity of blood pressure measurements from two devices', 'timeFrame': '1 hour', 'description': 'The agreement of systolic and diastolic blood pressure measurements of both monitoring devices will be evaluated.'}, {'measure': 'Similarity of heart rate measurements from two devices', 'timeFrame': '1 hour', 'description': 'The agreement of heart rate measurements of both monitoring devices will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blood pressure measurement', 'heart rate measurement', 'smartwatch'], 'conditions': ['Blood Pressure', 'Heart Rate']}, 'referencesModule': {'references': [{'pmid': '32049066', 'type': 'BACKGROUND', 'citation': 'Hahnen C, Freeman CG, Haldar N, Hamati JN, Bard DM, Murali V, Merli GJ, Joseph JI, van Helmond N. Accuracy of Vital Signs Measurements by a Smartwatch and a Portable Health Device: Validation Study. JMIR Mhealth Uhealth. 2020 Feb 12;8(2):e16811. doi: 10.2196/16811.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to verify the accuracy of blood pressure and heart rate measurement by Samsung smartwatches compared to a standard monitor of vital signs used in intensive care units.', 'detailedDescription': 'Recently, wearables, like smartwatches, have been gaining new possibilities in monitoring biological signals and they are used for home monitoring of health conditions. Heart rate measurement is a common function of smartwatches, some smartwatch models even measure blood pressure. The study aims to compare the measurement of blood pressure and heart rate using the latest smartwatch with a vital signs monitor used in clinical practice. Blood pressure and heart rate measurements will be taken by hand from the watch and the vital signs monitor simultaneously. The agreement of the measurements of both devices will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy volunteers\n\nExclusion Criteria:\n\n* any acute illness\n* pregnancy\n* severe cardiovascular conditions\n* severe asthma or other severe respiratory conditions\n* diabetes\n* hypotension or hypertension'}, 'identificationModule': {'nctId': 'NCT05302193', 'briefTitle': 'Non-invasive Blood Pressure Measurement Using Samsung Smartwatch', 'organization': {'class': 'OTHER', 'fullName': 'Czech Technical University in Prague'}, 'officialTitle': 'Non-invasive Blood Pressure Measurement Using Samsung Smartwatch', 'orgStudyIdInfo': {'id': 'NIBPsmartwatch21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blood pressure and heart rate measurement', 'description': 'Calm measurement of blood pressure and heart rate simultaneously by smartwatch and vital signs monitor. Each participant will undergo this measurement a total of 6 times.', 'interventionNames': ['Other: Calm measurement of blood pressure and heart rate (before physical activity)', 'Other: Physical activity', 'Other: Calm measurement of blood pressure and heart rate (after physical activity)']}], 'interventions': [{'name': 'Calm measurement of blood pressure and heart rate (before physical activity)', 'type': 'OTHER', 'description': 'Simultaneous blood pressure and heart rate measurements at minutes 2 and 5.5 of the experiment.', 'armGroupLabels': ['Blood pressure and heart rate measurement']}, {'name': 'Physical activity', 'type': 'OTHER', 'description': 'Five minutes of physical activity, between times 7.5 min and 12.5 min of the experimental part. Riding on a spinning ergometer with a standardized load of 1 W/kg.', 'armGroupLabels': ['Blood pressure and heart rate measurement']}, {'name': 'Calm measurement of blood pressure and heart rate (after physical activity)', 'type': 'OTHER', 'description': 'Simultaneous blood pressure and heart rate measurements at times 15.5, 17, 20.5 and 22 minutes of the experimental part.', 'armGroupLabels': ['Blood pressure and heart rate measurement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27201', 'city': 'Kladno', 'country': 'Czechia', 'facility': 'Faculty of Biomedical Engineering, Czech Technical University in Prague', 'geoPoint': {'lat': 50.14734, 'lon': 14.10285}}], 'overallOfficials': [{'name': 'Veronika Rafl Huttova, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Czech Technical University in Prague'}, {'name': 'Jakub Rafl, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Czech Technical University in Prague'}, {'name': 'Martin Rozanek, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Czech Technical University in Prague'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Czech Technical University in Prague', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}