Experimental Exposure to Air Pollutants and Sympathetic Nerve Activity in Human Subjects
NCT ID: NCT01914783
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2013-07-31
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
TRIPLE
Study Groups
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ultrafine particles
Subjects will be exposed to ultrafine particles for three hours in an exposure chamber. During that time participants will perform intermittent bicycle ergometer training. Training intensity is adjusted individually to increase ventilation to 20 l/min/m². During exposure, heart rate will be monitored continuously via ECG. Blood pressure will be measured every 15 minutes. Ultrafine elemental carbon black particles are generated using a commercially available electric spark generator. Particle number, mass, and size distribution will be monitored during exposure.
ultrafine particles
exposure to ultrafine particles
ultrafine particles and ozone
Subjects will be exposed to ultrafine particles for three hours in an exposure chamber. During that time participants will perform intermittent bicycle ergometer training. Training intensity is adjusted individually to increase ventilation to 20 l/min/m². During exposure, heart rate will be monitored continuously via ECG. Blood pressure will be measured every 15 minutes. Ultrafine elemental carbon black particles are generated using a commercially available electric spark generator. Particle number, mass, and size distribution will be monitored during exposure.Ozone is generated from medical oxygen in order to maintain a concentration of 250 ppb.
ultrafine particles and ozone
exposure to ultrafine particles and ozone
clean air
Subjects will be exposed to clean air for three hours in an exposure chamber controlled for temperature, humidity, and gas/particle composition. During that time they will perform intermittent bicycle ergometer training for 15 minutes alternating with 15 minutes rest. Training intensity is adjusted individually to increase ventilation to 20 l/min/m². During exposure, heart rate will be monitored continuously via ECG. The blood pressure will be measured in time intervals of 15 minutes.
clean air
Exposure to clean air.
Interventions
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ultrafine particles
exposure to ultrafine particles
ultrafine particles and ozone
exposure to ultrafine particles and ozone
clean air
Exposure to clean air.
Eligibility Criteria
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Inclusion Criteria
* Signed written informed consent.
Exclusion Criteria
* 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.
50 Years
ALL
Yes
Sponsors
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Fraunhofer-Institute of Toxicology and Experimental Medicine
OTHER
Hannover Medical School
OTHER
Responsible Party
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Prof. Dr. Jens Jordan
Professor Dr. med. Jens Jordan
Locations
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Hannover Medical School
Hanover, , Germany
Countries
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Central Contacts
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Facility Contacts
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Marcus May, MD
Role: primary
References
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Tank J, Biller H, Heusser K, Holz O, Diedrich A, Framke T, Koch A, Grosshennig A, Koch W, Krug N, Jordan J, Hohlfeld JM. Effect of acute ozone induced airway inflammation on human sympathetic nerve traffic: a randomized, placebo controlled, crossover study. PLoS One. 2011 Apr 8;6(4):e18737. doi: 10.1371/journal.pone.0018737.
Other Identifiers
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MHH-Particles EK-6142
Identifier Type: -
Identifier Source: org_study_id