Face Masks to Reduce the Adverse Effects of Diesel Exhaust Inhalation (FM-RADIO)
|ClinicalTrials.gov Identifier: NCT02729129|
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : April 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Other: Diesel exhaust exposure with filtered facemask Other: Diesel exhaust exposure with sham mask||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|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|
|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.
- 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.
- 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).
- Blood pressure [ Time Frame: 24 hours ]Ambulatory blood pressure monitors are worn by subjects for 24 hours during and after exposure.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729129
|Umeå, Sweden, 90185|
|Principal Investigator:||Jenny A Bosson, MD, PhD||Umeå University|