Skip to content

Face Masks to Reduce the Adverse Effects of Diesel Exhaust Inhalation

Face Masks to Reduce the Adverse Effects of Diesel Exhaust Inhalation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02729129
Acronym
FM-RADIO
Enrollment
22
Registered
2016-04-06
Start date
2014-04-30
Completion date
2016-02-29
Last updated
2016-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Diesel exhaust, Air pollution, Intervention, Plethysmography

Brief summary

Air pollution exposure is a major environmental and public health concern. The findings from controlled exposure studies have given biological plausibility to the epidemiological associations, and have defined important pathways that may be amenable to intervention. Ultimately, there is a need to address how one may protect the public from these detrimental effects. Two studies have been performed assessing the cardiovascular effects of wearing a face mask in a highly polluted urban area in China in healthy volunteers and patients with coronary heart disease. These demonstrated lower blood pressure and increased heart rate variability when wearing a face mask as compared to not. The investigators aim to test if wearing a highly efficient face mask during exposure to dilute diesel exhaust abrogates the well-known adverse cardiovascular effects.

Interventions

OTHERDiesel exhaust exposure with filtered facemask

1 hour exposure to dilute diesel exhaust (approximate particle matter concentration 300 mcg/m3) during intermittent exercise while wearing a filtered facemask.

OTHERDiesel exhaust exposure with sham mask

1 hour exposure to dilute diesel exhaust (approximate particle matter concentration 300 mcg/m3) during intermittent exercise while wearing a sham facemask.

Sponsors

University of Edinburgh
CollaboratorOTHER
Umeå University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* Healthy males * Non-smoking * All subjects undergo a general health examination and are required to have normal clinical examination, ECG, blood tests and lung function

Exclusion criteria

* Metabolic or cardiovascular disease * Asthma or other respiratory disease * Respiratory infection within 2 weeks of the study * Antioxidant- and/or vitamin supplementation within 1 week prior to, as well as during the course of the study. (incl vitamin C, Acetylcysteine) * Smokers or regular snus usage

Design outcomes

Primary

MeasureTime frameDescription
Vascular vasomotor function2 hoursForearm venous occlusion plethysmography to measure forearm blood flow during unilateral intrabrachial infusion of endothelial-dependent and -independent vasodilators. Assessment is shown in ml/100ml tissue/min.

Secondary

MeasureTime frameDescription
Fibrinolytic function2 hoursTissue plasminogen activator was analysed in blood samples taken after bradykinin infusions in order to assess fibrinolytic function (ng/ml).
Blood pressure24 hoursAmbulatory blood pressure monitors are worn by subjects for 24 hours during and after exposure.
Heart rate variability24 hoursHolter ECGs are worn by subjects during and for 24 hours post exposure. This will be assessed for heart rate variability (HRV).

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026