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Face Masks to Reduce the Adverse Effects of Diesel Exhaust Inhalation (FM-RADIO)

U

Umeå University

Status

Completed

Conditions

Healthy

Treatments

Other: Diesel exhaust exposure with filtered facemask
Other: Diesel exhaust exposure with sham mask

Study type

Interventional

Funder types

Other

Identifiers

NCT02729129
14-12-31M

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

22 participants in 2 patient groups

Commercially available highly-efficient facemask
Experimental group
Treatment:
Other: Diesel exhaust exposure with filtered facemask
Sham facemask
Sham Comparator group
Treatment:
Other: Diesel exhaust exposure with sham mask

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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