Experimental Exposure to Air Pollutants and Sympathetic Nerve Activity in Human Subjects — Particles  

Cardiovascular Morbidity Clinical Trial

Official title: Experimental Exposure to Air Pollutants and Sympathetic Nerve Activity in Human Subjects

Status Recruiting

Clinical Trial Summary

The primary hypothesis of the study is that in healthy elderly subjects experimental exposure to air pollutants increases sympathetic nervous system activity compared with sham (clean air) exposure. The secondary hypothesis of the study is that combined experimental exposure to air pollutants (particles + ozone) increases sympathetic nervous system activity to a greater extent than does the exposure to particles alone.

Clinical Trial Description

In a randomized, double-blind, and cross-over fashion, the participants will be exposed to clean air, ultrafine particles, or ultrafine particles and ozone in an exposure chamber. The investigators will determine blood pressure, heart rate, respiration as well as cardiac output and directly record sympathetic vasomotor tone using the microneurography technique. To elucidate the underlying mechanisms through which particles and ozone affect the autonomic nervous system, the investigators will assess the local and systemic inflammatory response as well as the changes in neurotrophic factors in sputum and blood. In addition, the activation of inflammatory cells in sputum and blood will be analyzed at different points in time after exposures. Changes in sympathetic activity will be correlated with the degree of airway inflammation and oxidative stress assessed in induced sputum and blood. This study will provide important insight in the mechanisms through which air pollution, particularly ultrafine particle exposure, increases cardiovascular risk in human subjects and generate a human model for mechanistic and therapeutic studies. ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiovascular Morbidity

• NCT number: NCT01914783
• Study type: Interventional
• Source: Hannover Medical School
• Contact: Marcus May, MD
• Phone: +49 511 532
• Email: may.marcus@mh-hannover.de
• Status: Recruiting
• Phase: N/A
• Start date: July 2013
• Completion date: December 2015