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

April 6, 2016 updated by: Jenny Bosson, Umeå University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Umeå, Sweden, 90185
        • Umeå University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Commercially available highly-efficient facemask
Other: 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.
SHAM_COMPARATOR: Sham facemask
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 hours
Blood pressure
Time Frame: 24 hours
Ambulatory blood pressure monitors are worn by subjects for 24 hours during and after exposure.
24 hours
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).
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

University of Edinburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (ACTUAL)

February 1, 2015

Study Completion (ACTUAL)

February 1, 2016

Study Registration Dates

First Submitted

March 18, 2016

First Submitted That Met QC Criteria

April 5, 2016

First Posted (ESTIMATE)

April 6, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

April 7, 2016

Last Update Submitted That Met QC Criteria

April 6, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-12-31M

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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