Face Masks to Reduce the Adverse Effects of Diesel Exhaust Inhalation

NCT ID: NCT02729129

Last Updated: 2016-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2016-02-29

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Blinding Strategy: TRIPLE

Study Groups

Commercially available highly-efficient facemask

Group Type: EXPERIMENTAL

Diesel exhaust exposure with filtered facemask

Intervention Type: OTHER

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

Sham facemask

Group Type: SHAM_COMPARATOR

Diesel exhaust exposure with sham mask

Intervention Type: OTHER

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

Interventions

Diesel 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.

Intervention Type: OTHER

Diesel 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Edinburgh

OTHER

Sponsor Role: collaborator

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Jenny Bosson

PhD, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jenny A Bosson, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

Umeå University

Umeå, , Sweden

Countries

Sweden

Other Identifiers

14-12-31M

Identifier Type: -

Identifier Source: org_study_id