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

November 24, 2025 updated by: Jose Guillermo CEDENO LAURENT, ScD, Rutgers, The State University of New Jersey

A Controlled Human Environmental Study Evaluating the Impacts of Cognitive Functions During the Exposure of Simulated Wildfire-Related Air Pollution (WRAP).

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

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Jersey
      • Piscataway, New Jersey, United States, 08854
        • Rutgers-EOHSI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
1 hour exposure to simulated wildfire smoke (300 ug/m3 PM)
1 hour exposure to clean (HEPA-filtered) air (0 ug/m3 PM)
Experimental: 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).
1 hour exposure to simulated wildfire smoke (300 ug/m3 PM)
1 hour exposure to clean (HEPA-filtered) air (0 ug/m3 PM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in plasma P-tau 217 concentration from pre-exposure to post-exposure
Time Frame: Immediately before, immediately after each 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jose G Cedeno-Laurent, ScD, Rutgers, The State University of New Jersey: New Brunswick/Piscataway Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2025

Primary Completion (Actual)

November 20, 2025

Study Completion (Actual)

November 20, 2025

Study Registration Dates

First Submitted

August 25, 2025

First Submitted That Met QC Criteria

August 25, 2025

First Posted (Estimated)

September 3, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro2025001070

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy Participants

Clinical Trials on Simulated wildfire smoke exposure

Subscribe