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OpenTrials
Completed

NCT Number: NCT02729129

Face Masks to Reduce the Adverse Effects of Diesel Exhaust Inhalation

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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Umeå University

Umeå, 90185, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diesel exhaust exposure with filtered facemask

Other

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

Diesel exhaust exposure with sham mask

Other

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

Primary outcomes

  1. Vascular vasomotor function

    Time frame: 2 hours

    Forearm 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 outcomes

  1. Fibrinolytic function

    Time frame: 2 hours

    Tissue plasminogen activator was analysed in blood samples taken after bradykinin infusions in order to assess fibrinolytic function (ng/ml).

  2. Blood pressure

    Time frame: 24 hours

    Ambulatory blood pressure monitors are worn by subjects for 24 hours during and after exposure.

  3. Heart rate variability

    Time frame: 24 hours

    Holter ECGs are worn by subjects during and for 24 hours post exposure. This will be assessed for heart rate variability (HRV).

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • University of Edinburgh

Registry information

Acronym: FM-RADIO

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Apr 6, 2016
Registry last updated
Apr 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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