- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01256957
Effect of HEPA Air Filters on Subclinical Markers of Cardiovascular Health (WEST)
December 1, 2016 updated by: Ryan Allen, Simon Fraser University
Assessing the Impact of Wood Stove Interventions on Air Quality
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
British Columbia
-
Burnaby, British Columbia, Canada, V5A 1S6
- Simon Fraser University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 19 years or older
- Non-smoking household
- Lives in study region (Smithers or Telkwa British Columbia)
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
|
|
Active Comparator: Indoor air HEPA filtration
HEPA filters operating in the participant's bedroom and living room.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reactive hyperemia index
Time Frame: After 1 week of air filtration
|
After 1 week of air filtration
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
C-reactive protein
Time Frame: After 1 week of filtration
|
After 1 week of filtration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ryan Allen, PhD, Simon Fraser University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
April 1, 2009
Study Completion (Actual)
April 1, 2009
Study Registration Dates
First Submitted
December 8, 2010
First Submitted That Met QC Criteria
December 8, 2010
First Posted (Estimate)
December 9, 2010
Study Record Updates
Last Update Posted (Estimate)
December 5, 2016
Last Update Submitted That Met QC Criteria
December 1, 2016
Last Verified
December 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 869329
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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