NCT05323240

Health Effects of Repeated Exposure to Low Levels of Concentrated Ambient Particles in Healthy Young Volunteers

Repeated Exposure Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: U.S. EPA Human Studies Facility · Federal
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

Purpose: To determine whether 3-day consecutive exposures to levels of fine particulate matter (PM2.5) 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 hr/day) and three consecutive days of PM2.5 (approximately 35 µg/m3; 4 hr/day) 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.

Conditions

• Air Pollution

Interventions

Type	Name	Description
OTHER	PM exposure	To determine whether 3-day consecutive exposures to levels of fine particulate matter (PM2.5) that are close to the current 24-hr national standard will cause changes in inflammatory and cardiopulmonary endpoints.
OTHER	Filtered air exposure	To determine whether 3-day consecutive exposures to filtered air will cause changes in inflammatory and cardiopulmonary endpoints.

Timeline

• Start date: 2022-05-12
• Primary completion: 2024-06-20
• Completion: 2025-12-20
• First posted: 2022-04-12
• Last updated: 2023-11-28

Locations

1 site across 1 country: United States