Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-02-20 @ 6:33 PM
Study NCT ID:
NCT05401435
Status:
UNKNOWN
Last Update Posted:
2022-06-02
First Post:
2022-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliability of Measuring Blood Pressure With a Smartwatch
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006339', 'term': 'Heart Rate'}], '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'}]}}, '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 single measurement of blood pressure and heart rate on each participant. Measurements are repeated 2 times a day for 28 days. The functioning of two measuring devices is compared.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-01', 'studyFirstSubmitDate': '2022-05-23', 'studyFirstSubmitQcDate': '2022-06-01', 'lastUpdatePostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in long-term similarity of blood pressure measurements from two devices between two consecutive calibrations', 'timeFrame': '28 days', 'description': 'The long-term agreement of systolic and diastolic blood pressure measurements of both monitoring devices between two consecutive smartwatch calibrations will be evaluated. This means that we evaluate the changes in the similarity of measured blood pressures over a period of 28 days.'}, {'measure': 'Change in long-term similarity of heart rate measurements from two devices', 'timeFrame': '28 days', 'description': 'The long-term agreement of heart rate measurements of both monitoring devices will be evaluated. This means that we evaluate the changes in the similarity of measured heart rates over a period of 28 days.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['blood pressure measurement', 'heart rate measurement', 'smartwatch'], 'conditions': ['Blood Pressure', 'Heart Rate']}, 'referencesModule': {'references': [{'pmid': '31423912', 'type': 'BACKGROUND', 'citation': 'van Helmond N, Freeman CG, Hahnen C, Haldar N, Hamati JN, Bard DM, Murali V, Merli GJ, Joseph JI. The accuracy of blood pressure measurement by a smartwatch and a portable health device. Hosp Pract (1995). 2019 Oct;47(4):211-215. doi: 10.1080/21548331.2019.1656991. Epub 2019 Aug 26.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to verify the long-term accuracy of blood pressure and heart rate measurements by Samsung smartwatches between two consecutive calibrations compared to a standard digital tonometer used in clinical practice and for home measurement of these vital parameters.', 'detailedDescription': 'Recently, smartwatches can measure a wide range of biological signals, including heart rate and blood pressure. The short-term reliability of blood pressure measurements after the required calibration has been studied, but long-term reliability is still a question. The aim of the project is to experimentally evaluate the reliability of long-term blood pressure measurement with a Samsung smart watch between two consecutive calibrations over a period of 28 days in comparison with a digital tonometer (Omron) approved as a medical device. Volunteers will measure blood pressure and heart rate manually twice a day from a smartwatch and a digital tonometer simultaneously. The agreement of the measurements of both devices will be evaluated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 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': 'NCT05401435', 'briefTitle': 'Reliability of Measuring Blood Pressure With a Smartwatch', 'organization': {'class': 'OTHER', 'fullName': 'Czech Technical University in Prague'}, 'officialTitle': 'Reliability of Measuring Blood Pressure With a Smartwatch', 'orgStudyIdInfo': {'id': 'NIBPsmartwatch22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Blood pressure and heart rate measurement', 'description': 'Resting blood pressure and heart rate measurement regularly one value in the morning and evening for 28 days. The volunteer measures the parameters simultaneously on both devices (smartwatch and digital tonometer). In total, each participant will undergo this measurement 56 times.', 'interventionNames': ['Other: Resting measurement of blood pressure and heart rate']}], 'interventions': [{'name': 'Resting measurement of blood pressure and heart rate', 'type': 'OTHER', 'description': 'Simultaneous blood pressure and heart rate measurement every morning and evening during the duration of the experiment (28 days).', 'armGroupLabels': ['Blood pressure and heart rate measurement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27201', 'city': 'Kladno', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Barbora Nezpevakova, Bc', 'role': 'CONTACT', 'email': 'nezpebar@fbmi.cvut.cz', 'phone': '+420728096216'}, {'name': 'Veronika Rafl Huttova, MSc', 'role': 'CONTACT', 'email': 'huttover@fbmi.cvut.cz'}], 'facility': 'Faculty of Biomedical Engineering, Czech Technical University in Prague', 'geoPoint': {'lat': 50.14734, 'lon': 14.10285}}], 'centralContacts': [{'name': 'Barbora Nezpevakova, Bc.', 'role': 'CONTACT', 'email': 'nezpebar@fbmi.cvut.cz', 'phone': '+420728096216'}, {'name': 'Veronika Rafl Huttova, MSc', 'role': 'CONTACT', 'email': 'huttover@fbmi.cvut.cz', 'phone': '+420224355049'}], 'overallOfficials': [{'name': 'Barbora Nezpevakova, Bc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Czech Technical University in Prague'}, {'name': 'Veronika Rafl Huttova, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Czech Technical University in Prague'}, {'name': 'Martin Rozanek, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Czech Technical University in Prague'}, {'name': 'Jakub Rafl, 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'}}}}