NCT02277002

Brief Summary

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 9, 2014

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 28, 2014

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

March 2, 2015

Status Verified

February 1, 2015

Enrollment Period

1 month

First QC Date

October 9, 2014

Last Update Submit

February 26, 2015

Conditions

Keywords

Cabin Air FiltrationParticulate MatterCommuter ExposureTraffic Related Air Pollution

Outcome Measures

Primary Outcomes (1)

  • Variation in cardiopulmonary function

    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 Outcomes (4)

  • Changes in neuropsychological Function

    5 hours

  • Changes in endothelial function

    5 hours

  • Changes in levels of Hypothalamic-Pituitary-Adrenal (HPA) Axis

    5 hours

  • Fraction of Exhaled Nitric Oxyde

    5 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants are exposed to unfiltered cabin air

Other: Placebo

Cabin Air Filter

ACTIVE COMPARATOR

Participants are exposed to filtered cabin air

Device: Cabin Air Filtration

Interventions

Cabin Air Filter
PlaceboOTHER

No Cabin Air Filtration

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy Individuals;
  • non-smoking.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guy-Favreau Complex

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Gary Mallach

    Health Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Air Health Effects Researcher

Study Record Dates

First Submitted

October 9, 2014

First Posted

October 28, 2014

Study Start

October 1, 2014

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

March 2, 2015

Record last verified: 2015-02

Locations