Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2026-02-20 @ 11:50 PM
Study NCT ID:
NCT03319056
Status:
COMPLETED
Last Update Posted:
2019-05-23
First Post:
2017-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Indoor Air and Children Health Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011660', 'term': 'Pulmonary Heart Disease'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061808', 'term': 'Air Filters'}], 'ancestors': [{'id': 'D005374', 'term': 'Filtration'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-21', 'studyFirstSubmitDate': '2017-10-18', 'studyFirstSubmitQcDate': '2017-10-21', 'lastUpdatePostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Levels of lung function indicators', 'timeFrame': '10 weekdays for intervention (active or sham) and 2 wash-out months', 'description': 'Lung function test was conducted including forced expiratory volume in one second (FEV1) and peak expiratory flow (PEF).'}], 'secondaryOutcomes': [{'measure': 'Changes in autonomic cardiac function', 'timeFrame': '10 weekdays for intervention (active or sham) and 2 wash-out months', 'description': 'Ambulatory electrocardiogram (ECG) was monitored including heart rate (HR) and heart rate variability (HRV).'}, {'measure': 'Level of respiratory inflammation', 'timeFrame': '10 weekdays for intervention (active or sham) and 2 wash-out months', 'description': 'Fractional exhaled nitric oxide (FeNO) test was conducted.'}, {'measure': 'Changes in ST-segment elevation', 'timeFrame': '10 weekdays for intervention (active or sham) and 2 wash-out months', 'description': 'Ambulatory electrocardiogram (ECG) was monitored.'}, {'measure': 'Levels of oxidative stress in Exhaled Breath Condensate (EBC)', 'timeFrame': '10 weekdays for intervention (active or sham) and 2 wash-out months', 'description': 'EBC was collected using a designated device for oxidative stress analysis.'}, {'measure': 'Levels of urinary metabolomics', 'timeFrame': '10 weekdays for intervention (active or sham) and 2 wash-out months', 'description': 'Urine samples were collected for metabolomics analysis.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiopulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to investigate the cardiopulmonary health effects of indoor air purification and different indoor environmental factors among school students in Beijing.', 'detailedDescription': 'This randomized, double-blind crossover study was conducted to explore the cardiopulmonary effects of ionization air purification among 48 children in Beijing. Real or sham purification was performed in classrooms for 5 weekdays in a random order with a 2-month wash-out period. During the study periods, different indoor environmental factors were monitored including size-fractionated particulate matter (PM), black carbon (BC), ozone, carbon dioxide (CO2), negative air ions (NAI), noise, temperature and relative humidity, which were controlled as confounders in the analysis of the effects of indoor air purification. In addition, we analyzed the cardiopulmonary effects of those environmental factors on the children.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* living in Beijing for more than two consecutive years;\n* living in school dormitories from Monday to Friday.\n\nExclusion Criteria:\n\n* suffering any health condition;\n* having asthma or thoracic surgery history.'}, 'identificationModule': {'nctId': 'NCT03319056', 'briefTitle': 'Indoor Air and Children Health Study', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Cardiopulmonary Health Effects of Indoor Air Purification and Different Indoor Environmental Factors Among School Children in Beijing', 'orgStudyIdInfo': {'id': 'FDeng17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Real purification', 'description': 'Air purifier turned on', 'interventionNames': ['Other: Air purifier']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham purification', 'description': 'Air purifier turned off', 'interventionNames': ['Other: Air purifier']}], 'interventions': [{'name': 'Air purifier', 'type': 'OTHER', 'description': 'active- or sham-mode air purifier used in 6 classrooms in a school with a crossover design', 'armGroupLabels': ['Real purification', 'Sham purification']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'School of Pubic Health, Peking University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Furong Deng, PhD&MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD & PhD, Professor, Deputy Director of Department of Occupational & Environmental Health Sciences', 'investigatorFullName': 'Furong Deng', 'investigatorAffiliation': 'Peking University'}}}}