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Commuter Air Pollution Intervention Study (CAPI)

Primary Purpose

Cognitive Function, Cardiopulmonary Function, Saliva Stress Hormones

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Cabin Air Filtration
Placebo
Sponsored by
Health Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Function focused on measuring Cabin Air Filtration, Particulate Matter, Commuter Exposure, Traffic Related Air Pollution

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Guy-Favreau Complex

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Cabin Air Filter

Arm Description

Participants are exposed to unfiltered cabin air

Participants are exposed to filtered cabin air

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in neuropsychological Function
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.
Changes in endothelial function
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.
Changes in levels of Hypothalamic-Pituitary-Adrenal (HPA) Axis
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.
Fraction of Exhaled Nitric Oxyde
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.

Full Information

First Posted
October 9, 2014
Last Updated
February 26, 2015
Sponsor
Health Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02277002
Brief Title
Commuter Air Pollution Intervention Study
Acronym
CAPI
Official Title
Reducing Commuter Air Pollutant Exposure by Cabin Air Filtration
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Health Canada

4. Oversight

5. Study Description

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Function, Cardiopulmonary Function, Saliva Stress Hormones, Air Pollution Exposure, Lung Inflammation
Keywords
Cabin Air Filtration, Particulate Matter, Commuter Exposure, Traffic Related Air Pollution

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants are exposed to unfiltered cabin air
Arm Title
Cabin Air Filter
Arm Type
Active Comparator
Arm Description
Participants are exposed to filtered cabin air
Intervention Type
Device
Intervention Name(s)
Cabin Air Filtration
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
No Cabin Air Filtration
Primary Outcome Measure Information:
Title
Variation in cardiopulmonary function
Description
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.
Time Frame
5 hours
Secondary Outcome Measure Information:
Title
Changes in neuropsychological Function
Description
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.
Time Frame
5 hours
Title
Changes in endothelial function
Description
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.
Time Frame
5 hours
Title
Changes in levels of Hypothalamic-Pituitary-Adrenal (HPA) Axis
Description
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.
Time Frame
5 hours
Title
Fraction of Exhaled Nitric Oxyde
Description
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.
Time Frame
5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Mallach
Organizational Affiliation
Health Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guy-Favreau Complex
City
Montreal
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

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Commuter Air Pollution Intervention Study

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