Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-01-04 @ 5:10 PM
Study NCT ID:
NCT01256957
Status:
COMPLETED
Last Update Posted:
2016-12-05
First Post:
2010-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of HEPA Air Filters on Subclinical Markers of Cardiovascular Health
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-01', 'studyFirstSubmitDate': '2010-12-08', 'studyFirstSubmitQcDate': '2010-12-08', 'lastUpdatePostDateStruct': {'date': '2016-12-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reactive hyperemia index', 'timeFrame': 'After 1 week of air filtration'}], 'secondaryOutcomes': [{'measure': 'C-reactive protein', 'timeFrame': 'After 1 week of filtration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Endothelial Function', 'Oxidative Stress', 'Systemic Inflammation']}, 'referencesModule': {'references': [{'pmid': '21257787', 'type': 'DERIVED', 'citation': 'Allen RW, Carlsten C, Karlen B, Leckie S, van Eeden S, Vedal S, Wong I, Brauer M. An air filter intervention study of endothelial function among healthy adults in a woodsmoke-impacted community. Am J Respir Crit Care Med. 2011 May 1;183(9):1222-30. doi: 10.1164/rccm.201010-1572OC. Epub 2011 Jan 21.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the ability of portable high efficiency particle air (HEPA) filters to reduce exposures to PM2.5 and woodsmoke air pollution indoors and to improve subclinical indicators of microvascular function, systemic inflammation, and oxidative stress among healthy adult participants.', 'detailedDescription': 'The investigators will use portable HEPA filters in a single-blind randomized crossover design. Each participant\'s home will be monitored for two consecutive seven-day periods, during which time two HEPA units (one in the bedroom and one in the main living room) will be operated indoors. During one 7-day period the HEPA filters will be operated normally, and during the other period the HEPA unit will be operated without the internal filter in place (i.e., "placebo filtration"), thus blinding participants to the filters\' status. The order of filtration or non-filtration will be random. At the end of each 7-day period microvascular function will be assessed, blood will be collected for assessment of systemic inflammatory markers, and urine will be collected for assessment of oxidative stress markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 19 years or older\n* Non-smoking household\n* Lives in study region (Smithers or Telkwa British Columbia)\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01256957', 'acronym': 'WEST', 'briefTitle': 'Effect of HEPA Air Filters on Subclinical Markers of Cardiovascular Health', 'organization': {'class': 'OTHER', 'fullName': 'Simon Fraser University'}, 'officialTitle': 'Assessing the Impact of Wood Stove Interventions on Air Quality', 'orgStudyIdInfo': {'id': '869329'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Indoor air HEPA filtration', 'description': "HEPA filters operating in the participant's bedroom and living room.", 'interventionNames': ['Device: HEPA filter']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control'}], 'interventions': [{'name': 'HEPA filter', 'type': 'DEVICE', 'otherNames': ['Honeywell model 50300', 'Honeywell model 18150'], 'armGroupLabels': ['Indoor air HEPA filtration']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5A 1S6', 'city': 'Burnaby', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Simon Fraser University', 'geoPoint': {'lat': 49.26636, 'lon': -122.95263}}], 'overallOfficials': [{'name': 'Ryan Allen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Simon Fraser University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Simon Fraser University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of British Columbia', 'class': 'OTHER'}, {'name': 'Health Canada', 'class': 'OTHER_GOV'}, {'name': 'Ministry of Environment, British Columbia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ryan Allen', 'investigatorAffiliation': 'Simon Fraser University'}}}}