Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT05035420
Status:
COMPLETED
Last Update Posted:
2025-09-05
First Post:
2021-09-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Noninvasive Multimodal Biosensing Device for Screening and Monitoring Response to Treatment of Infectious Respiratory Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09-03', 'completionDateStruct': {'date': '2025-08-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2021-09-03', 'studyFirstSubmitQcDate': '2021-09-03', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare performance of a multimodal biosensor device with commercial systems for measuring vital physiological signals including cardiac, respiratory, and tissue oxygenation in individuals at rest.', 'timeFrame': 'End of study', 'description': 'Compare performance of two multimodal NIRS biosensor devices with commercial systems for measuring vital physiological signals including cardiac, respiratory, and tissue oxygenation in individuals at rest.'}], 'secondaryOutcomes': [{'measure': 'Characterize arterial oxygen saturation (SpO2), peripheral oxygen saturation (StO2) and cerebral oxygen saturation (ScO2) during respiratory perturbations.', 'timeFrame': 'End of study', 'description': 'We would like to know if arterial oxygen saturation (SpO2), peripheral oxygen saturation (StO2) and cerebral oxygen saturation (ScO2) are also sensitive to respiratory changes. Although these parameters are all related, they may exhibit unique behavior due to autoregulatory mechanisms in the brain and differences between arterial and tissue saturation.'}, {'measure': 'Compare measured changes in cardiac, respiratory, and tissue oxygenation parameters during induced hypercapnia, breath holding, and paced breathing exercises between the biosensor and commercial systems.', 'timeFrame': 'End of study', 'description': 'Accuracy of the biosensor not only depends on comparison to baseline values but also should correlate during induced changes.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['point-of-care multimodal biosensing device', 'COVID-19 screening and monitoring'], 'conditions': ['COVID-19', 'Upper Respiratory Infection', 'Lower Respiratory Infection']}, 'referencesModule': {'references': [{'pmid': '26877058', 'type': 'BACKGROUND', 'citation': 'Sakudo A. Near-infrared spectroscopy for medical applications: Current status and future perspectives. Clin Chim Acta. 2016 Apr 1;455:181-8. doi: 10.1016/j.cca.2016.02.009. Epub 2016 Feb 12.'}, {'pmid': '16044829', 'type': 'BACKGROUND', 'citation': 'Chiu WT, Lin PW, Chiou HY, Lee WS, Lee CN, Yang YY, Lee HM, Hsieh MS, Hu CJ, Ho YS, Deng WP, Hsu CY. Infrared thermography to mass-screen suspected SARS patients with fever. Asia Pac J Public Health. 2005;17(1):26-8. doi: 10.1177/101053950501700107.'}, {'pmid': '25838515', 'type': 'BACKGROUND', 'citation': 'Abay TY, Kyriacou PA. Reflectance Photoplethysmography as Noninvasive Monitoring of Tissue Blood Perfusion. IEEE Trans Biomed Eng. 2015 Sep;62(9):2187-95. doi: 10.1109/TBME.2015.2417863. Epub 2015 Mar 30.'}], 'seeAlsoLinks': [{'url': 'https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2021-CH-0028.html', 'label': 'NIH Clinical Center Detailed Web Page'}]}, 'descriptionModule': {'briefSummary': 'Background:\n\nThe COVID-19 outbreak has strained the health care system. New tools are needed for diagnostic testing and monitoring of people who have the virus. Researchers want to test a device they hope can screen, detect, and monitor symptoms linked to respiratory diseases like COVID-19.\n\nObjective:\n\nTo evaluate and validate a device that measures breathing, body temperature, heart rate, and tissue oxygenation.\n\nEligibility:\n\nHealthy adults ages 18 and older with no flu-like symptoms and no current signs of infection, cough, fever, or sneezing.\n\nDesign:\n\nParticipants will have a physical exam. Their vital signs will be taken.\n\nParticipants will sit in a chair. They will be monitored for 60 to 80 minutes while they do the following tasks:\n\nRest for 10 minutes. They will repeat this after each task.\n\nHold their breath for up to 2 minutes and then rest for 2 minutes. They will do this task 3 times.\n\nPace-breathe with breathing rates of 10, 20, and 30 breaths per minute. They will do this task 2 times.\n\nBreathe air that has 5% of carbon dioxide for 5 minutes.\n\nDuring these tasks, data will be collected and recorded with a pulse oximeter, thermometer, respiratory belt, and spirometer.\n\nParticipants will fill out questionnaires related to their daily activity (medication intake, exercise, smoking, and drinking).\n\nParticipation will last for 2 to 3 hours.', 'detailedDescription': 'Study Description:\\<TAB\\>\n\nThis observational pilot study will characterize the performance of a multimodal biosensor device (a portable and a wireless NIRS device, PPG and temperature sensor) in measuring human vital signs, which later will be explored as a point-of-care method for screening and treatment response monitoring of individuals with an infectious respiratory illness. The devices will measure heart, respiratory, and tissue oxygenation parameters in healthy subjects at rest and during induced hypercapnia, breath holding, and paced breathing.\n\nObjectives:\n\n\\<TAB\\>\n\nPrimary objective: Compare performance of two multimodal NIRS biosensor devices with commercial systems for measuring vital physiological signals including cardiac, respiratory, and tissue oxygenation in individuals at rest.\n\nSecondary objective: Compare measured changes in cardiac, respiratory, and tissue oxygenation parameters during induced hypercapnia, breath holding, and paced breathing exercises between the biosensor and commercial systems.\n\nExploratory objective: Characterize arterial oxygen saturation (SpO2), peripheral oxygen saturation (StO2) and cerebral oxygen saturation (ScO2) during respiratory perturbations.\n\nEndpoints:\\<TAB\\>\n\nPrimary endpoint: Paired differences, Lin s concordance correlation coefficient and Bland-Altman analysis for the following parameters: Biosensor tissue microvascular oxygenation level (StO2), respiratory rate (RR), respiratory effort index (REI), heart rate (HR) and heart rate variability (HRV).\n\nSecondary endpoint: Paired differences, Lin s concordance correlation coefficient and Bland-Altman analysis for the following parameters: Biosensor tissue microvascular oxygenation level (StO2), respiratory rate (RR), respiratory effort index (REI), heart rate (HR) and heart rate variability (HRV) during induced hypercapnia, breath holding, and paced breathing exercises.\n\nExploratory endpoint: Arterial oxygen saturation (SpO2), peripheral oxygen saturation (StO2) and cerebral oxygen saturation (ScO2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '78 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Provision of signed and dated informed consent form.\n* Stated willingness to comply with all study procedures and availability for the duration of the study.\n* Male or female aged 18 years or greater.\n* In good general health as evidenced by medical history with no signs of cough, sneeze and upper respiratory symptoms.\n* Body temperature in normal range (afebrile, temperature \\< 100.4 (Infinite) F) on the day of the experiment.\n\nEXCLUSION CRITERIA:\n\n* Any skin disease.\n* Fever (Temperature greater than or equal to 100.4 degrees F).\n* Any past or present cardiovascular or pulmonary diseases.\n* Known adverse reaction to latex.\n* Any medical condition that, in the opinion of the Principal Investigator would preclude the inclusion of a patient onto this research study.\n* Unable or unwilling to give informed consent.\n* Individuals with known respiratory conditions.\n* Individuals who are currently taking medication that may cause methemoglobinemia such as nitrates derivatives, sulfonamides, dapsone, phenacetin, phenazopyridine, some local anesthetics such as prilocaine, topical anesthetics such as emla cream, benzocaine.\n* Individuals with history of seizure.\n* Smokers and those on narcotics.\n* Pregnant women are excluded due to risk associated to hypercapnia risk'}, 'identificationModule': {'nctId': 'NCT05035420', 'briefTitle': 'A Noninvasive Multimodal Biosensing Device for Screening and Monitoring Response to Treatment of Infectious Respiratory Diseases', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'A Pilot Study to Evaluate A Noninvasive Multimodal Biosensing Device for Screening and Monitoring Response to Treatment of Infectious Respiratory Diseases', 'orgStudyIdInfo': {'id': '210028'}, 'secondaryIdInfos': [{'id': '21-CH-0028'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Volunteer', 'description': 'Healthy Volunteer', 'interventionNames': ['Device: Fitbit', 'Device: Douglas Bag', 'Device: Periflux 6000 EPOS', 'Device: BIOPAC', 'Device: Flowmet', 'Device: NIRS']}], 'interventions': [{'name': 'Fitbit', 'type': 'DEVICE', 'description': 'Performance of the NIRS biosensor will be explored in comparison to this commercial wearable.', 'armGroupLabels': ['Healthy Volunteer']}, {'name': 'Douglas Bag', 'type': 'DEVICE', 'description': 'The Douglas Bag will be used for inducing hypercapnia.', 'armGroupLabels': ['Healthy Volunteer']}, {'name': 'Periflux 6000 EPOS', 'type': 'DEVICE', 'description': 'Tissue oxygen saturation measured by the Periflux 6000 will be compared with peripheral tissue saturation measured with the NIRS biosensor both at rest and during the induced hypercapnia, paced breathing and breath holding.', 'armGroupLabels': ['Healthy Volunteer']}, {'name': 'BIOPAC', 'type': 'DEVICE', 'description': 'The BIOPAC system will be used to record the PPG signal, cardiovascular hemodynamics, and respiratory parameters in order to noninvasively monitor the heart rate, heart rate variability, respiratory rate, respiratory effort index, and arterial oxygen saturation.', 'armGroupLabels': ['Healthy Volunteer']}, {'name': 'Flowmet', 'type': 'DEVICE', 'description': 'Flowmet will be used for a measurement of arterial blood flow within the finger or toe. Flowmet outputs a PPG waveform that will be compared with the NIRS biosensor.', 'armGroupLabels': ['Healthy Volunteer']}, {'name': 'NIRS', 'type': 'DEVICE', 'description': 'a. Each subject will be monitored with the multimodal system for 10 minutes while sitting quiescent on a chair in resting position. All screening index parameters will be collected and recorded. b. Each subject will be studied for approximately 60-80 minutes while being exposed to a mild Hypercapnia (5% CO2), paced breathing and breath holding followed by a 10-minute recovery time after each task.', 'armGroupLabels': ['Healthy Volunteer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Institutes of Health Clinical Center', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Amir H Gandjbakhche, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'We are working on deciding if we will share IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}