Ignite Creation Date:
2024-05-06 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 2:29 PM
Study NCT ID:
NCT05323240
Status:
RECRUITING
Last Update Posted:
2023-11-28
First Post:
2021-11-29
Brief Title:
Health Effects of Repeated Exposure to Low Levels of Concentrated Ambient Particles in Healthy Young Volunteers
Sponsor:
US EPA Human Studies Facility
Organization:
US EPA Human Studies Facility
Study Overview
Official Title:
Repeated Exposure Study
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose To determine whether 3-day consecutive exposures to levels of fine particulate matter PM25 that are close to the current 24-hr national standard will cause changes in inflammatory and cardiopulmonary endpoints in healthy young individuals
Participants 20 healthy males and females aged 18-35 years
Procedures methods Subjects will be randomly exposed to three consecutive days of filtered air 4 hrday and three consecutive days of PM25 approximately 35 µgm3 4 hrday in an exposure chamber Blood collection for inflammatory factors such as C-reactive protein CRP clotting factors heart rate variability HRV spirometry and a symptom questionnaire will be conducted before and after each exposure
Participants 20 healthy males and females aged 18-35 years
Procedures methods Subjects will be randomly exposed to three consecutive days of filtered air 4 hrday and three consecutive days of PM25 approximately 35 µgm3 4 hrday in an exposure chamber Blood collection for inflammatory factors such as C-reactive protein CRP clotting factors heart rate variability HRV spirometry and a symptom questionnaire will be conducted before and after each exposure
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None