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Effect of HEPA Air Filters on Subclinical Markers of Cardiovascular Health (WEST)

Primary Purpose

Endothelial Function, Oxidative Stress, Systemic Inflammation

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

HEPA filter

About this trial

This is an interventional prevention trial for Endothelial Function

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

19 years or older
Non-smoking household
Lives in study region (Smithers or Telkwa British Columbia)

Exclusion Criteria:

Sites / Locations

Simon Fraser University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Indoor air HEPA filtration

Control

Arm Description

HEPA filters operating in the participant's bedroom and living room.

Control

Outcomes

Primary Outcome Measures

Reactive hyperemia index

Secondary Outcome Measures

C-reactive protein

Full Information

NCT ID

NCT01256957

First Posted

December 8, 2010

Last Updated

December 1, 2016

Sponsor

Simon Fraser University

Collaborators

University of British Columbia, Health Canada, Ministry of Environment, British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT01256957

Brief Title

Effect of HEPA Air Filters on Subclinical Markers of Cardiovascular Health

Acronym

WEST

Official Title

Assessing the Impact of Wood Stove Interventions on Air Quality

Study Type

Interventional

2. Study Status

Record Verification Date

December 2010

Overall Recruitment Status

Completed

Study Start Date

November 2008 (undefined)

Primary Completion Date

April 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Simon Fraser University

Collaborators

University of British Columbia, Health Canada, Ministry of Environment, British Columbia

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Endothelial Function, Oxidative Stress, Systemic Inflammation

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Indoor air HEPA filtration

Arm Type

Active Comparator

Arm Description

HEPA filters operating in the participant's bedroom and living room.

Arm Title

Control

Arm Type

No Intervention

Arm Description

Control

Intervention Type

Device

Intervention Name(s)

HEPA filter

Other Intervention Name(s)

Honeywell model 50300, Honeywell model 18150

Primary Outcome Measure Information:

Title

Reactive hyperemia index

Time Frame

After 1 week of air filtration

Secondary Outcome Measure Information:

Title

C-reactive protein

Time Frame

After 1 week of filtration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 19 years or older Non-smoking household Lives in study region (Smithers or Telkwa British Columbia) Exclusion Criteria: -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ryan Allen, PhD

Organizational Affiliation

Simon Fraser University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Simon Fraser University

City

Burnaby

State/Province

British Columbia

ZIP/Postal Code

V5A 1S6

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

21257787

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.

Results Reference

derived

Learn more about this trial

Effect of HEPA Air Filters on Subclinical Markers of Cardiovascular Health

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