Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-01-03 @ 12:58 PM
Study NCT ID:
NCT01166867
Status:
COMPLETED
Last Update Posted:
2022-11-01
First Post:
2010-07-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Study Using Photo-plethysmographic (PPG) Camera
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-28', 'studyFirstSubmitDate': '2010-07-20', 'studyFirstSubmitQcDate': '2010-07-20', 'lastUpdatePostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-07-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['assessment'], 'conditions': ['Infant Development']}, 'descriptionModule': {'briefSummary': 'The researcher want to use video signals to monitor heart rate, respiration rate and oxygen saturation using Photo-plethysmography (PPG) as the underlying mechanism for the method: periodic changes in skin reflectance, induced by the cardio-vascular wave, are measured using light.', 'detailedDescription': 'The Researcher want to use ambient light to monitor heart rate, respiration rate and oxygen saturation (SpO2) in infant patients in a hospital setting. The plethysmographic signal is typically strong on children. This provides a reliable heart rate monitor. However, to measure oxygen saturation, a quantitative value of the strength at two wavelength regions (green and red) is required. It is also not known if the normal ambient light is spectrally appropriate to analyze the video signals for oxygenation. With the current prototype of our system, we can monitor heart rate reliably and estimate oxygen saturation in adults, using normal artificial light or daylight, entering through a window.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Months', 'minimumAge': '1 Minute', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'infant', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infant and toddler\n\nExclusion Criteria:\n\n* non-infant'}, 'identificationModule': {'nctId': 'NCT01166867', 'briefTitle': 'A Pilot Study Using Photo-plethysmographic (PPG) Camera', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Photo-plethysmographic (PPG) Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants.', 'orgStudyIdInfo': {'id': '20097046'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infant Development', 'description': 'Photo-plethysmography monitoring', 'interventionNames': ['Device: Photo-plethysmography monitoring']}], 'interventions': [{'name': 'Photo-plethysmography monitoring', 'type': 'DEVICE', 'description': 'monitoring vital sign in infant', 'armGroupLabels': ['Infant Development']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'overallOfficials': [{'name': 'Stuart Nelson, M.D, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beckman Laser Institute University of California Irvine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital of Orange County", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Willem Verkruysse, Ph.D., Associate Specialist', 'investigatorFullName': 'Beckman Laser Institute and Medical Center', 'investigatorAffiliation': 'University of California, Irvine'}}}}