Commuter Air Pollution Intervention Study (CAPI)

February 26, 2015 updated by: Gary Mallach, Health Canada

Reducing Commuter Air Pollutant Exposure by Cabin Air Filtration

Traffic related air pollution is a well-recognised and much studied contributor to smog and is linked to a number of adverse health outcomes. Although traffic pollutants can travel long distances, exposure to the highest levels of the raw emissions can occur closest to the source; e.g. in a car in dense traffic conditions. Time spent in-vehicle may contribute up to half of commuters' daily exposure to certain air pollutants. Most new cars now have or allow for a cabin air filter, but it is not known how well cabin air filtration can reduce exposure to traffic-related air pollution.

This intervention study will measure commuters' exposure to air pollutants in rush hour traffic. It will evaluate the impact of this exposure on stress hormones in saliva, and short term cardiopulmonary health indicators such as blood pressure, heart rate variability and respiratory inflammation. It will also look at effects on cognition (mental processing and judgement) in this real world environment where any deficit could be important to safety. In addition, the study will examine whether cabin air filtration can reduce the exposure to traffic related air pollutants and result in improvements in short term cardiopulmonary and cognitive function. This research will contribute to our understanding of how this environment contributes to Canadians' overall air pollution exposure as well as the potential health impacts. It will also test a potentially valuable and economical means of reducing exposure to traffic related air pollution in a commuting environment. The study may also guide the future implementation of the use of cabin filters as an exposure reduction intervention.

Overall Project Objectives:

Can cabin air filtration effectively reduce exposure to traffic related air pollution? Does commuter exposure to air pollution affect short term stress, and cardiopulmonary and cognitive function? Can cabin air filtration mitigate the health effects of commuters' exposure to air pollution?

Study Overview

Study Type

Interventional

Enrollment (Actual)

48

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

    • Quebec
      • Montreal, Quebec, Canada
        • Guy-Favreau Complex

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy Individuals;
  • non-smoking.

Exclusion Criteria:

  • Smokers;
  • living in a smoking household;
  • currently experiencing seasonal allergies;
  • suffering from heart rhythm problems or heart conditions;
  • regularly taking corticosteroid medication;
  • pregnant or breastfeeding;
  • allergic to latex;
  • sensitivity to adhesives

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants are exposed to unfiltered cabin air
No Cabin Air Filtration
Active Comparator: Cabin Air Filter
Participants are exposed to filtered cabin air

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation in cardiopulmonary function
Time Frame: 5 hours
Heart Rate Variability (HRV) will be measured from continuous ambulatory electrocardiogram (ECG) recordings collected during the study protocol. ECG will be worn for the duration of the study day period (approximately 5 hours), including a period prior to exposure and following exposure.
5 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in neuropsychological Function
Time Frame: 5 hours
Assessment of neuropsychological function can be achieved using a battery of mood and cognitive tests. The study will use a battery of tests that are comercially available through CANTAB, the mini-mental state exam designed by University of Cambridge. Battery will be administered before and after exposure.
5 hours
Changes in endothelial function
Time Frame: 5 hours
Endothelial function will be assessed using the non-invasive, FDA approved Endo-Pat2000 instrument. Test administration involves continuous measurement of blood flow and vascular tone in the fingertips of both index fingers, before, during and after an occlusion of blood flow to the non-dominant hand. Blood flow is occluded using a standard blood pressure cuff positioned on the upper arm. Measures will be carried out before and after exposure.
5 hours
Changes in levels of Hypothalamic-Pituitary-Adrenal (HPA) Axis
Time Frame: 5 hours
In the present study, salivary cortisol will be assessed as a non-invasive measure of HPA axis activation. Saliva sample collection will be done with Salivette swabs twice before exposure, once during exposure and twice following exposure.
5 hours
Fraction of Exhaled Nitric Oxyde
Time Frame: 5 hours
Lung inflammation will be assessed as the fraction of nitric oxide (NO) exhaled in the participants' breath using a portable, FDA approved, fractional exhaled nitric oxide (FENO) measurement device, the NIOX Mino. Measures will be carried out before and after exposure.
5 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Gary Mallach, Health Canada

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

October 1, 2014

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

October 9, 2014

First Submitted That Met QC Criteria

October 27, 2014

First Posted (Estimate)

October 28, 2014

Study Record Updates

Last Update Posted (Estimate)

March 2, 2015

Last Update Submitted That Met QC Criteria

February 26, 2015

Last Verified

February 1, 2015

More Information

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.

Clinical Trials on Cognitive Function

Clinical Trials on Placebo

3
Subscribe