Wildfire Related Air Pollution Exposure and Cognitive Function Pilot Study

NCT07151235 | Completed

• 1 other identifier: Pro2025001070
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy Participants

Keywords

wildfires; air pollution; ultrafine particles; cognitive function

Outcome Measures

Primary Outcomes (1)

• Changes in plasma P-tau 217 concentration from pre-exposure to post-exposure

  Using blood samples collected pre- and post-exposure, the primary outcome will be assessed by measurement of plasma phosphorylated tau at threonine 217 (p-tau217) using an ultrasensitive immunoassay

  Immediately before, immediately after each exposure

Study Arms (2)

Exposure to simulated wildfire smoke, then exposure to clean air

EXPERIMENTAL

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).

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

Exposure to clean air, then exposure to simulated wildfire smoke

EXPERIMENTAL

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).

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

Interventions

Simulated wildfire smoke exposure OTHER

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

Exposure to clean air, then exposure to simulated wildfire smoke; Exposure to simulated wildfire smoke, then exposure to clean air

Clean Air exposure OTHER

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

Exposure to clean air, then exposure to simulated wildfire smoke; Exposure to simulated wildfire smoke, then exposure to clean air

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Rutgers-EOHSI

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

Pemphigus and fogo selvagem

Study Officials

• Jose G Cedeno-Laurent, ScD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: outside laboratories processing blood samples
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be exposed to two conditions (clean air and wildfire smoke) in random order.

Study Record Dates

• First Submitted: August 25, 2025
• First Posted: September 3, 2025
• Study Start: September 18, 2025
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)