Status:
UNKNOWN
Experimental Exposure to Air Pollutants and Sympathetic Nerve Activity in Human Subjects
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
Fraunhofer-Institute of Toxicology and Experimental Medicine
Conditions:
Cardiovascular Morbidity
Eligibility:
All Genders
50+ years
Phase:
NA
Brief 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. T...
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 wi...
Eligibility Criteria
Inclusion
- Elderly man or postmenopausal woman older than 50 years of age.
- Signed written informed consent.
Exclusion
- Smoker.
- Cardiovascular and/or pulmonary disease.
- Medication with relevant impact on autonomic system function, e. g. norepinephrine reuptake inhibitors. Stable medication with slight to moderate autonomic effects is tolerable.
- Subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
- Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Subject unlikely to comply with protocol, e. g. uncooperative attitude or unlikelihood of completing the study.
- Known hypersensitivity to ozone.
- History of drug or alcohol abuse. Particles Study - Protocol version: October 19, 2012 14
- Blood donation of more than 500 mL during the previous 3 months.
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01914783
Start Date
July 1 2013
End Date
December 1 2015
Last Update
August 2 2013
Active Locations (1)
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1
Hannover Medical School
Hanover, Germany, 30625