Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02729129
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : April 7, 2016
Sponsor:
Collaborator:
University of Edinburgh
Information provided by (Responsible Party):
Jenny Bosson, Umeå University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Healthy Other: Diesel exhaust exposure with filtered facemask Other: Diesel exhaust exposure with sham mask Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Official Title: Face Masks to Reduce the Adverse Effects of Diesel Exhaust Inhalation
Study Start Date : April 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2016
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729129


Locations
Layout table for location information
Sweden
Umeå University
Umeå, Sweden, 90185
Sponsors and Collaborators
Umeå University
University of Edinburgh
Investigators
Layout table for investigator information
Principal Investigator: Jenny A Bosson, MD, PhD Umeå University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jenny Bosson, PhD, MD, Umeå University
ClinicalTrials.gov Identifier: NCT02729129    
Other Study ID Numbers: 14-12-31M
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: April 7, 2016
Last Verified: April 2016
Keywords provided by Jenny Bosson, Umeå University:
Diesel exhaust
Air pollution
Intervention
Plethysmography
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes