Face Masks to Reduce the Adverse Effects of Diesel Exhaust Inhalation

NCT02729129 | Completed

• 1 other identifier: 14-12-31M
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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

Keywords

Diesel exhaust; Air pollution; Intervention; Plethysmography

Outcome Measures

Primary Outcomes (1)

• Vascular vasomotor function

  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.

  2 hours

Secondary Outcomes (3)

• Fibrinolytic function

  2 hours

• Blood pressure

  24 hours

• Heart rate variability

  24 hours

Study Arms (2)

Commercially available highly-efficient facemask

EXPERIMENTAL

Other: Diesel exhaust exposure with filtered facemask

Sham facemask

SHAM COMPARATOR

Other: Diesel exhaust exposure with sham mask

Interventions

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.

Commercially available highly-efficient 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.

Sham facemask

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Umeå University: lead
• University of Edinburgh: collaborator

Study Sites (1)

Umeå University

Umeå, 90185, Sweden

Location

Study Officials

• Jenny A Bosson, MD, PhD

  Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, MD

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: April 6, 2016
• Study Start: April 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2016
• Last Updated: April 7, 2016

Record last verified: 2016-04

Locations

SE (1)