Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-26 @ 11:07 AM
Study NCT ID:
NCT04688112
Status:
UNKNOWN
Last Update Posted:
2023-09-07
First Post:
2020-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Validation Study of Selfie Technology for Assessment of Vital Signs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-05', 'studyFirstSubmitDate': '2020-12-23', 'studyFirstSubmitQcDate': '2020-12-23', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heart Rate', 'timeFrame': 'Baseline', 'description': 'Heart Rate (beats/minute) assessed 3 times at 10 minute intervals on one occasion'}, {'measure': 'Respiratory Rate', 'timeFrame': 'Baseline', 'description': 'Respiratory Rate in respirations/min assessed visually or oximeter if it has the capability assessed 3 times at 10 minute intervals on one occasion'}, {'measure': 'Heart Rate Variability', 'timeFrame': 'Baseline', 'description': 'HRV (ms) assessed 3 times at 10 minute intervals on one occasion'}, {'measure': 'Blood Pressure', 'timeFrame': 'Baseline', 'description': 'Systolic and Diastolic Blood Pressure assessed 3 times at 10 minute intervals on one occasion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Photoplethysmography', 'Video Selfie', 'Vital Signs', 'Blood Pressure', 'Smartphone', 'DocMe', 'Heart Rate', 'Respiratory Rate'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '31599362', 'type': 'BACKGROUND', 'citation': 'Barszczyk A, Lee K. Measuring Blood Pressure: from Cuff to Smartphone. Curr Hypertens Rep. 2019 Oct 10;21(11):84. doi: 10.1007/s11906-019-0990-3.'}, {'pmid': '31382766', 'type': 'BACKGROUND', 'citation': 'Luo H, Yang D, Barszczyk A, Vempala N, Wei J, Wu SJ, Zheng PP, Fu G, Lee K, Feng ZP. Smartphone-Based Blood Pressure Measurement Using Transdermal Optical Imaging Technology. Circ Cardiovasc Imaging. 2019 Aug;12(8):e008857. doi: 10.1161/CIRCIMAGING.119.008857. Epub 2019 Aug 6.'}, {'pmid': '32492902', 'type': 'BACKGROUND', 'citation': 'Chowdhury MH, Shuzan MNI, Chowdhury MEH, Mahbub ZB, Uddin MM, Khandakar A, Reaz MBI. Estimating Blood Pressure from the Photoplethysmogram Signal and Demographic Features Using Machine Learning Techniques. Sensors (Basel). 2020 Jun 1;20(11):3127. doi: 10.3390/s20113127.'}, {'pmid': '17477684', 'type': 'BACKGROUND', 'citation': 'Humphreys K, Ward T, Markham C. Noncontact simultaneous dual wavelength photoplethysmography: a further step toward noncontact pulse oximetry. Rev Sci Instrum. 2007 Apr;78(4):044304. doi: 10.1063/1.2724789.'}, {'pmid': '23938616', 'type': 'BACKGROUND', 'citation': 'Kong L, Zhao Y, Dong L, Jian Y, Jin X, Li B, Feng Y, Liu M, Liu X, Wu H. Non-contact detection of oxygen saturation based on visible light imaging device using ambient light. Opt Express. 2013 Jul 29;21(15):17464-71. doi: 10.1364/OE.21.017464.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare accuracy of DocMe, a video technology developed by DocMe Health Technologies, with previously validated medical devices used for measurements of heart rate, heart rate variability, respiratory rate and blood pressure in adults.', 'detailedDescription': 'Photoplethysmography (PPG) makes uses of low-intensity infrared (IR) light. When light travels through biological tissues, it is absorbed by bones, skin pigments and both venous and arterial blood. However, as light is more strongly absorbed by blood than the surrounding tissues, the changes in blood flow can be detected by PPG sensors as changes in the intensity of light.\n\nThe signal from PPG is proportional to the quantity of blood flowing through the blood vessels and even small changes in blood volume can be detected using this method. Analysis of the waveform can provide information on a range of physiological measurements affecting the cardiovascular and respiratory systems. PPG is widely used in medicine in the form of pulse oximeters using sensors applied to peripheral digits.\n\nRecently, it has been shown that PPG data can be obtained using images acquired from videos taken using the camera on smartphones and there is now a significant and growing body of published literature to support this.\n\nDocMe Health Technologies has developed a system of obtaining these data using a 15 second video selfie.\n\nAt this time, the technology has been shown to be reasonably accurate when compared to home devices in healthy subjects. However, to make the technology more widely useful, the results obtained by video selfies need to be formally validated.\n\nThe aim of the study therefore is to compare measurements obtained from video selfies with measurements taken using already validated machines in the same patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We will seek to adhere to ISO (81060-2:2018)guidelines and AHA BP consensus standards.\n\n* at least 5% population reference range systolic BP \\<100mmHg\n* at least 5% population reference range systolic BP \\>160mmHg\n* at least 20% population reference range systolic BP \\>140mmHg\n* at least 5% population reference range diastolic BP \\<60mmHg\n* at least 5% population reference range diastolic BP \\>100mmHg\n* at least 20% population reference range diastolic BP \\>80mmHg', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18 - 90 years old).\n* Participants must be willing and able to give informed consent for participation in the study, and considered fit for the study by the nurse.'}, 'identificationModule': {'nctId': 'NCT04688112', 'briefTitle': 'Validation Study of Selfie Technology for Assessment of Vital Signs', 'organization': {'class': 'INDUSTRY', 'fullName': 'DocMe Technologies Ltd'}, 'officialTitle': 'A Validation Study Comparing the Heart Rate, Respiratory Rate, Heart Rate Variability and Blood Pressure Obtained by Video Selfie Using the DocMe® Technology With Those Obtained by Direct Measurement in Healthy People', 'orgStudyIdInfo': {'id': 'PRFX-2020-01-DocMe'}}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 9DU', 'city': 'Oxford', 'state': 'Oxfordshire', 'country': 'United Kingdom', 'facility': 'Oxford University Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Alex T Novak, MRCGP FRCEM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oxford University Hospitals NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DocMe Technologies Ltd', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Oxford University Hospitals NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}