Wildfire Related Air Pollution Exposure and Cognitive Function Pilot Study

NCT ID: NCT07151235

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-18
• Study Completion Date: 2025-11-20

Brief Summary

This study will examine how breathing wildfire-related air pollution (WRAP) for one hour affects healthy adults. The main question the study will answer if the effect of WRAP exposure on p-tau, a blood marker of cognitive decline. The changes in p-tau concentrations after exposure to WRAP will be compared to the changes in p-tau after exposure to clean air.

Participants will:

• Have 2 study visits - one visit with exposure to clean air and one visit with exposure to simulated wildfire smoke
• Have blood drawn before and after each exposure
• Complete cognitive tests and memory tasks before and after each exposure

Detailed Description

• Exposures will take place in a booth-like exposure chamber (1 x 0.7 x 1.8 m) with glass upper panels. One person will be exposed at a time.
• Simulated wildfire smoke will be generated by burning pine wood at a temperature that mimics smoldering combustion. The levels of smoke introduced into the exposure chamber are similar to those found during outdoor bonfires and wildfire events. The levels of particulate matter (PM) will be closely monitored during the exposure.

Conditions

Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Exposure to simulated wildfire smoke, then exposure to clean air

At the first study visit the subject undergoes a 1-hour chamber exposure to simulated wildfire smoke (300 ug/m3 Particulate Matter). After a 1-week washout period, the subject undergoes a 1-hour chamber exposure to clean air (0 ug/m3 PM).

Group Type: EXPERIMENTAL

Simulated wildfire smoke exposure

Intervention Type: OTHER

1 hour exposure to simulated wildfire smoke (300 ug/m3 PM)

Clean Air exposure

Intervention Type: OTHER

1 hour exposure to clean (HEPA-filtered) air (0 ug/m3 PM)

Exposure to clean air, then exposure to simulated wildfire smoke

At the first study visit the subject undergoes a 1-hour chamber exposure to clean air (0 ug/m3 PM). After a 1-week washout period, the subject undergoes a 1-hour chamber exposure to simulated wildfire smoke (300 ug/m3 PM).

Group Type: EXPERIMENTAL

Simulated wildfire smoke exposure

Intervention Type: OTHER

1 hour exposure to simulated wildfire smoke (300 ug/m3 PM)

Clean Air exposure

Intervention Type: OTHER

1 hour exposure to clean (HEPA-filtered) air (0 ug/m3 PM)

Interventions

Simulated wildfire smoke exposure

1 hour exposure to simulated wildfire smoke (300 ug/m3 PM)

Intervention Type: OTHER

Clean Air exposure

1 hour exposure to clean (HEPA-filtered) air (0 ug/m3 PM)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Healthy
• Non smoker
• Weight at least 110 pounds
• Between ages 18 and 40 years old

Exclusion Criteria

• Claustrophobia or not comfortable in enclosed spaces.
• Colorblindness.
• Inability to hear verbal instructions.
• Cardiovascular disease which, in the opinion of the investigator, would elevate the participant's risk of adverse effects to WRAP exposure. This includes a history of stroke.
• Diabetes requiring the use of insulin.
• Pregnancy (A pregnancy test will be provided to you).
• Current asthma (an asthma attack within the past five years).
• History of childhood asthma.
• Medications which may affect cognition such as beta-blockers and CNS depressants.
• Respiratory symptoms in the previous 4 weeks (cough, wheezing, shortness of breath, etc.) which, in the opinion of the investigator, would elevate the participant's risk of adverse effects to WRAP exposure.
• Use of sedating cold/allergy medications in the previous week.
• Use of marijuana in the previous week.
• Consumption of alcohol in the previous 24 hours.
• Kidney or liver disease.
• Thyroid disease.
• High blood pressure.
• Cancer.
• Parkinson's disease.
• Pacemaker.
• Hay fever.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Jose Guillermo CEDENO LAURENT, ScD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose G Cedeno-Laurent, ScD

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey: New Brunswick/Piscataway Campus

Locations

Rutgers-EOHSI

Piscataway, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro2025001070

Identifier Type: -

Identifier Source: org_study_id