Wildfire Related Air Pollution Exposure and Cognitive Function Pilot Study (WRAP)

Rutgers The State University of New Jersey

Status: Completed

Conditions: Healthy Participants

Treatments: Other: Simulated wildfire smoke exposure; Other: Clean Air exposure

Study type: Interventional

Funder types: Other

Identifiers

NCT07151235

Pro2025001070

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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12 participants in 2 patient groups

Exposure to simulated wildfire smoke, then exposure to clean air

Experimental group

Description:

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).

Treatment:

Other: Clean Air exposure

Other: Simulated wildfire smoke exposure

Exposure to clean air, then exposure to simulated wildfire smoke

Experimental group

Description:

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).

Treatment:

Other: Clean Air exposure

Other: Simulated wildfire smoke exposure