Trials / Unknown
UnknownNCT01914783
Experimental Exposure to Air Pollutants and Sympathetic Nerve Activity in Human Subjects
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Hannover Medical School · Academic / Other
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | ultrafine particles | exposure to ultrafine particles |
| OTHER | ultrafine particles and ozone | exposure to ultrafine particles and ozone |
| OTHER | clean air | Exposure to clean air. |
Timeline
- Start date
- 2013-07-01
- Primary completion
- 2015-12-01
- Completion
- 2015-12-01
- First posted
- 2013-08-02
- Last updated
- 2013-08-02
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01914783. Inclusion in this directory is not an endorsement.