Ignite Creation Date:
2025-12-24 @ 12:30 PM
Ignite Modification Date:
2026-01-17 @ 1:37 AM
Study NCT ID:
NCT03747861
Status:
COMPLETED
Last Update Posted:
2020-02-18
First Post:
2018-11-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Measuring Accuracy of Wristband for Registration of ECG RR-Intervals for One Hand, SenceBand in Comparison to Holter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-01-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-14', 'studyFirstSubmitDate': '2018-11-17', 'studyFirstSubmitQcDate': '2018-11-17', 'lastUpdatePostDateStruct': {'date': '2020-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'RR interval accuracy', 'timeFrame': '5-minute intervals every 30 minutes within 24 hours', 'description': 'Accuracy of RR intervals estimating'}], 'secondaryOutcomes': [{'measure': 'RR-intervals passing', 'timeFrame': '5-minute intervals every 30 minutes within 24 hours of use', 'description': 'Frequency of passing of determination of RR-intervals'}, {'measure': 'HRV accuracy for time-domain measures', 'timeFrame': '5-minute intervals every 30 minutes within 24 hours', 'description': 'HRV accuracy for time-domain measures (MeanNN, SDNN, RMSSD, pNN50)'}, {'measure': 'HRV accuracy for frequency-domain measures', 'timeFrame': '5-minute intervals every 30 minutes within 24 hours', 'description': 'HRV accuracy for time-domain measures (VLF, LF, HF, LF / HF)'}, {'measure': 'HRV accuracy for time-domain measures', 'timeFrame': '24 hours intervals', 'description': 'HRV accuracy for time-domain measures (MeanNN, SDNN, RMSSD, pNN50)'}, {'measure': 'HRV accuracy for frequency-domain measures', 'timeFrame': '24 hours intervals', 'description': 'HRV accuracy for time-domain measures (VLF, LF, HF, LF / HF)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['R-R intervals', 'Heart rate', 'HRV'], 'conditions': ['HRV']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the measuring accuracy of the Wristband for registration of ECG RR intervals for one hand, SenceBand icompared to the Holter monitor (LabTech Ltd).', 'detailedDescription': 'Non-randomized, prospective, open clinical trial . The main purpose is to evaluate the measuring accuracy of the Wristband for registration of ECG RR intervals for one hand, SenceBand in real-world condition during 24-hours of routine duties in comparison to a predicate device (Holter monitor). For monitoring HRV each subject will put heart rate monitor SenceBand in the randomly assigned wrist and Holter monitor electrodes will be placed in standard configurations places. Data will be collected during routine duties. SenceBand will collect data from 5-minutes intervals each 30 minutes, Holter will collect data continuously over 24 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject has given written informed consent;\n2. Subject is male or female, aged 18-75;\n3. Subject has understood and complied with the requirements of the study protocol and;\n4. Subject is fluent in Ukrainian.\n\nExclusion Criteria:\n\n1. Subject has cardiac pacemakers;\n2. Subject is a pregnant woman;\n3. Subject has an allergy on polyurethane;\n4. Subject refers to vulnerable groups of the population;\n5. In investigator's opinion subject is not able physically or intellectually to fulfill the requirements of protocol."}, 'identificationModule': {'nctId': 'NCT03747861', 'briefTitle': 'Measuring Accuracy of Wristband for Registration of ECG RR-Intervals for One Hand, SenceBand in Comparison to Holter', 'organization': {'class': 'INDUSTRY', 'fullName': 'Planexta, Inc'}, 'officialTitle': 'An Open Clinical Study of Measuring Accuracy of RR- Intervals and Determining the Heart Rate Variability With a Wristband for Registration of ECG RR Intervals for One Hand, SenceBand Compared to the Holter Monitor.', 'orgStudyIdInfo': {'id': 'SenceBand-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Arm for HRV monitoring', 'description': 'For monitoring HRV each subject will put Wristband for registration of ECG RR intervals for one hand, SenceBand in the left wrist and Holter monitor electrodes will be placed in standard configurations places.', 'interventionNames': ['Device: SenceBand']}], 'interventions': [{'name': 'SenceBand', 'type': 'DEVICE', 'description': 'Wristband for registration of ECG RR intervals for one hand, SenceBand will collect data from 5-minutes intervals each 30 minute within 24 hours', 'armGroupLabels': ['Arm for HRV monitoring']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Kyiv', 'state': 'Kyiv Oblast', 'country': 'Ukraine', 'facility': 'Doctor Sam Medical Network'}], 'overallOfficials': [{'name': 'Yulia Kuznetsova-Arabuli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dr. Sam LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Planexta, Inc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Pharmaxi LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}