Healthy ParticipantsWRAPNCT07151235
Wildfire Related Air Pollution Exposure and Cognitive Function Pilot Study
A study testing Simulated wildfire smoke exposure and Clean Air exposure in people with Healthy Participants, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Simulated wildfire smoke exposure and Clean Air exposure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2025to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Non smoker
- Weight at least 110 pounds
- Between ages 18 and 40 years old
Who cannot join
- 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).
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- Simulated wildfire smoke exposure, Clean Air exposure
- Keywords
- wildfires, air pollution, ultrafine particles, cognitive function
- Medical subject headings
- Pemphigus and fogo selvagem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulated wildfire smoke exposureOther
1 hour exposure to simulated wildfire smoke (300 ug/m3 PM)
Clean Air exposureOther
1 hour exposure to clean (HEPA-filtered) air (0 ug/m3 PM)
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Simulated wildfire smoke exposure; Other: Clean Air exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Immediately before, immediately after each exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start18 Sep 2025
- Primary completion20 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be exposed to two conditions (clean air and wildfire smoke) in random order.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose Guillermo CEDENO LAURENT, ScD, Rutgers, The State University of New Jersey
- Investigators
- Jose G Cedeno-Laurent, ScD, Principal investigator, Rutgers, The State University of New Jersey: New Brunswick/Piscataway Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07151235
- Sponsor's protocol ID
- Pro2025001070
- Acronym
- WRAP
- Status last verified
- Nov 2025
- First submitted
- 25 Aug 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Human Environmental Study Evaluating the Impacts of Cognitive Functions During the Exposure of Simulated Wildfire-Related Air Pollution (WRAP).
- ClinicalTrials.gov ID
- NCT07151235
- Acronym / sponsor ID
- WRAP / Pro2025001070
- Conditions
- Healthy Participants
- Keywords
- wildfires, air pollution, ultrafine particles, cognitive function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 3 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be exposed to two conditions (clean air and wildfire smoke) in random order.
| Arm | Type | Receives |
|---|---|---|
| Exposure to simulated wildfire smoke, then exposure to clean air | Experimental | Other: Simulated wildfire smoke exposure, Other: Clean Air exposureAt 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). |
| Exposure to clean air, then exposure to simulated wildfire smoke | Experimental | Other: Simulated wildfire smoke exposure, Other: Clean Air exposureAt 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). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Non smoker
- Weight at least 110 pounds
- Between ages 18 and 40 years old
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulated wildfire smoke exposure1 hour exposure to simulated wildfire smoke (300 ug/m3 PM) | Other | Exposure to clean air, then exposure to simulated wildfire smoke, Exposure to simulated wildfire smoke, then exposure to clean air |
| Clean Air exposure1 hour exposure to clean (HEPA-filtered) air (0 ug/m3 PM) | Other | Exposure to clean air, then exposure to simulated wildfire smoke, Exposure to simulated wildfire smoke, then exposure to clean air |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose G Cedeno-Laurent, ScD principal investigator
Rutgers, The State University of New Jersey: New Brunswick/Piscataway Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulated wildfire smoke exposure and Clean Air exposure in people with Healthy Participants, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in plasma P-tau 217 concentration from pre-exposure to post-exposure (time frame: Immediately before, immediately after each exposure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.