Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2025-12-29 @ 11:58 PM
Study NCT ID:
NCT06098092
Status:
UNKNOWN
Last Update Posted:
2023-10-24
First Post:
2023-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Experimental Validation of the Long-term Accuracy of Blood Pressure Measurement Using a Smartwatch
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Interventional prospective single-arm study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2023-10-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-18', 'studyFirstSubmitDate': '2023-10-09', 'studyFirstSubmitQcDate': '2023-10-18', 'lastUpdatePostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure agreement between smartwatch and digital tonometer', 'timeFrame': '20-40 days', 'description': 'The agreement of Blood pressure measurements between smartwatch and medical grade reference digital tonometer'}], 'secondaryOutcomes': [{'measure': 'Heart rate agreement between smartwatch and digital tonometer', 'timeFrame': '20-40 days', 'description': 'The agreement of Heart rate measurements between smartwatch and medical grade reference digital tonometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Smartwatch', 'Blood pressure', 'Heart rate'], 'conditions': ['Hypertension', 'Blood Pressure']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to perform an experimental validation of the long-term accuracy of blood pressure measurement using the Samsung Galaxy Smartwatch', 'detailedDescription': "Blood pressure is one of the basic vital signs monitored and is one of the most important indicators of a patient's health status. Cardiovascular disease is one of the leading causes of death worldwide. One of the major risk factors for cardiovascular disease is hypertension, which is globally attributed to one third of deaths in the world population. To improve the prevention of hypertension, self-monitoring of blood pressure is increasingly recommended. This project involves an experimental validation of the long-term accuracy of blood pressure measurement using the Samsung Galaxy Smartwatch compared to a medical grade digital tonometer with a cuff placed on the arm."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteer\n\nExclusion Criteria:\n\n* post-traumatic conditions of the upper limbs\n* tattoos, birthmarks, injuries or diseases of the skin on the wrists of hands\n* cardiac arrhythmias\n* circulatory or peripheral varcular disease\n* aortic valve disease\n* myocardiopathy\n* other cardiovascular diseases\n* pregnancy\n* kidney disease\n* diabetes\n* neurotic disorder\n* haemostatic disorders\n* use of blood-thinning drugs'}, 'identificationModule': {'nctId': 'NCT06098092', 'acronym': 'BPLONG', 'briefTitle': 'Experimental Validation of the Long-term Accuracy of Blood Pressure Measurement Using a Smartwatch', 'organization': {'class': 'OTHER', 'fullName': 'Czech Technical University in Prague'}, 'officialTitle': 'Experimental Validation of the Long-term Accuracy of Blood Pressure Measurement Using a Smartwatch', 'orgStudyIdInfo': {'id': 'NVT_02_2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Long-term Blood pressure and Heart rate monitoring with reference digital tonometer and smartwatch', 'description': 'Measurement of a non-invasive Blood pressure and Heart rate using a reference medical grade digital tonometer Omron and a smartwatch Samsung Galaxy Watch during 20-40 days every morning and evening.', 'interventionNames': ['Other: Long-term non-invasive Blood pressure monitoring']}], 'interventions': [{'name': 'Long-term non-invasive Blood pressure monitoring', 'type': 'OTHER', 'otherNames': ['Long-term non-invasive Heart rate monitoring'], 'description': 'All measurements during the experiment include only non-invasive Blood pressure and Heart rate measurements. Measurements will be taken using a smartwatch attached to the wrist and a digital tonometer with a cuff placed on the other arm. Paired readings will be compared.', 'armGroupLabels': ['Long-term Blood pressure and Heart rate monitoring with reference digital tonometer and smartwatch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27201', 'city': 'Kladno', 'country': 'Czechia', 'facility': 'Czech Technical University in Prague', 'geoPoint': {'lat': 50.14734, 'lon': 14.10285}}], 'overallOfficials': [{'name': 'Jakub Rafl', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Czech Technical University'}]}, 'ipdSharingStatementModule': {'url': 'https://ventilation.fbmi.cvut.cz/data/', 'timeFrame': 'Unlimited from the time of processing complete measured data', 'ipdSharing': 'YES', 'description': 'The measured data will be shared publicly in the data repository on web page: https://ventilation.fbmi.cvut.cz/data/', 'accessCriteria': 'Publicly available to everyone'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Czech Technical University in Prague', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}