Cognitive FunctionCAPINCT02277002
Commuter Air Pollution Intervention Study
A study testing Cabin Air Filtration in people with Cognitive Function and Cardiopulmonary Function, run by Health Canada at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function, Cardiopulmonary Function, Saliva Stress Hormones
- What is being tested?
- Cabin Air Filtration
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2014to Nov 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Individuals;
- non-smoking.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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?
- Conditions
- Cognitive Function, Cardiopulmonary Function, Saliva Stress Hormones, Air Pollution Exposure, Lung Inflammation
- Being tested
- Cabin Air Filtration, Placebo
- Keywords
- Cabin Air Filtration, Particulate Matter, Commuter Exposure, Traffic Related Air Pollution
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cabin Air FiltrationDevice
PlaceboOther
No Cabin Air Filtration
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants are exposed to unfiltered cabin air Receives: Other: Placebo |
| Cabin Air Filter | Active comparator | Participants are exposed to filtered cabin air Receives: Device: Cabin Air Filtration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 hours
Secondary outcomes (4)
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.
Measured: 5 hours
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.
Measured: 5 hours
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.
Measured: 5 hours
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.
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Canada
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gary Mallach, Health Canada
- Investigators
- Gary Mallach, Principal investigator, Health Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02277002
- Sponsor's protocol ID
- REB 2014-0006
- Acronym
- CAPI
- Status last verified
- Feb 2015
- First submitted
- 9 Oct 2014
- Last updated
- 2 Mar 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Commuter Air Pollutant Exposure by Cabin Air Filtration
- ClinicalTrials.gov ID
- NCT02277002
- Acronym / sponsor ID
- CAPI / REB 2014-0006
- Conditions
- Cognitive Function, Cardiopulmonary Function, Saliva Stress Hormones, Air Pollution Exposure, Lung Inflammation
- Keywords
- Cabin Air Filtration, Particulate Matter, Commuter Exposure, Traffic Related Air Pollution
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Health CanadaOther government
- Study start
- Oct 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 28 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboParticipants are exposed to unfiltered cabin air |
| Cabin Air Filter | Active comparator | Device: Cabin Air FiltrationParticipants are exposed to filtered cabin air |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy Individuals;
- non-smoking.
Key exclusion criteria (8 listed)
- Smokers;
- living in a smoking household;
- currently experiencing seasonal allergies;
- suffering from heart rhythm problems or heart conditions;
- regularly taking corticosteroid medication;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cabin Air Filtration | Device | Cabin Air Filter |
| PlaceboNo Cabin Air Filtration | Other | Placebo |
Primary outcome
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.
4 secondary outcomes
Changes in neuropsychological Function
Time frame: 5 hours
Changes in endothelial function
Time frame: 5 hours
Changes in levels of Hypothalamic-Pituitary-Adrenal (HPA) Axis
Time frame: 5 hours
Fraction of Exhaled Nitric Oxyde
Time frame: 5 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2015.
Related trials for Cognitive Function
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
Recruiting
The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study
Obstructive Sleep Apnea, Cognitive Decline
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
RecruitingObservational study
Health, Imaging, and Cognition Across the Menopausal Transition
Menopause
Recruiting
The Efficacy of an IADL-based Non-immersive Virtual Reality Training Program to Enhance ADL Performance and Cognitive Function for Persons at Risk of Dementia
Cognitive Enhancement, Subjective Cognitive Decline (SCD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Mallach principal investigator
Health Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cabin Air Filtration in people with Cognitive Function and Cardiopulmonary Function, run by Health Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in cardiopulmonary function (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2015.