Air PollutionSENSENCT05843370
Modification of Ambient Air Pollution Exposure and Cardiopulmonary Outcomes by Socioeconomic Status and Nutrition
An observational study of Air Pollution and Pollution; Exposure, run by Environmental Protection Agency (EPA) at 1 site in United States.
Trial summary
The goal of this observational study is to compare the effects of air pollution exposure and nutrition between neighborhoods with high and low social vulnerability scores. The main questions this study aims to answer are: Does living in a neighborhood with high or low vulnerability influence the response of the heart… Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Air Pollution, Pollution; Exposure, Nutrition, Healthy
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2023to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population represents individuals living in neighborhoods ranked either at the top or bottom of the Social Vulnerability Index, a measure of community vulnerability.
Who may be able to join
- Aged 25-70 years old males and females.
- Residing in Zip Code Tabulation Area in Raleigh-Durham great triangle area representing high or low social vulnerability index (SVI).
- Continuous residence at the same address during previous one year.
Who cannot join
- Individuals with a diagnosis of COVID-19 and have persistent symptoms due to that infection (e.g., shortness of breath) or symptoms consistent with "long COVID".
- Individuals not "up to date" on their vaccinations for COVID-19. [which means a person who has received all recommended COVID-19 vaccines, including any booster dose(s) when eligible].
- Individuals who have difficulty to come to the HSF medical station on a weekday for data collection without assistance.
- Individuals have a history of heart arrhythmia, a pacemaker user, been diagnosed with arrhythmia and prescribed a medication to treat arrhythmia.
- Individuals have uncontrolled hypertension (>180 systolic, >110 diastolic)
- Individuals who are currently smoking (including vaping, hookah, e-cigarettes, including marijuana, CBD, and/or THC products) or have a smoking history within 1 year of study (defined as more than 1 pk/yr in the past year) or have a greater than/equal to a 5-pack year smoking history.
Show all 22Show fewer
- Individuals living with a smoker who smokes inside the house.
- Individuals who are regularly exposed to high levels of vapors, dust, gases, smoke, or fumes.
- Individuals who do not understand or speak English.
- Individuals who are taking β-blocker medications.
- Individuals who are on specific extreme diets, such as liquid diet, weight loss diet, or single diet.
- Individuals who are unwilling or unable to maintain their current dietary and medication pattern for the whole study.
- Individuals with bleeding or clotting disorders.
- Individuals who have skin allergy to tape or electrodes.
- Individuals who are pregnant or attempting to become pregnant.
- Individuals currently on dialysis
- Individuals who have unspecified illnesses, which in the judgment of the investigators might increase the risk associated with clinical procedures will be a basis for exclusion.
- Temporary Exclusion Criteria :
- Individuals who have had recent (within 6 months) abdominal and/or eye surgery, or been diagnosed with any type of hernia, as well as any other contraindications for raised intra-abdominal pressure.
- Individuals who have prolonged chest pain at rest (severe uncompensated angina pectoris) or inability to carry out any physical activity without chest discomfort.
- Individuals who have difficulty breathing when at rest or performing activities at daily living.
- Individuals who are having an acute respiratory illness within two weeks prior to any of the study visits.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
EPA Human Studies Facility
Chapel Hill, North Carolina, 27514
About this study
The goal of this observational study is to compare the effects of air pollution exposure and nutrition between neighborhoods with high and low social vulnerability scores. The main questions this study aims to answer are:
- Does living in a neighborhood with high or low vulnerability influence the response of the heart, lungs, and immune system to air pollution.
- Does nutritional status alter the association between air pollution exposure and changes in the heart, lungs, and immune system.
Read more
Participants (age 25-70 years) that live in neighborhoods ranked high or low on the Social Vulnerability Index (SVI) will take part in 3 visits. Each visit involves the following:
- Measurements of heart activity, lung function, and blood to measure changes that may be caused by air pollution.
- Questionnaires about the types of food eaten and activities that may modify exposure to air pollution.
- Estimation of air pollution exposure using a study iPhone. Participants will carry a study iPhone with them for 24 hours at each visit. The study iPhone runs an application (app) that estimates the amount of air pollution each participant is exposed to.
- Wearing silicone wristbands for a week before each study visit. Silicone wristbands absorb air pollutants and are later measured see the types and amounts of chemicals participants are exposed to.
Read the detailed description
Acute and chronic exposure to air pollution are well-established risk factors for all-cause mortality, mainly driven by cardiovascular and respiratory disease. The health effects of air pollution exposure have been shown to be mediated by a range of community level and personal factors, including the presence of preexisting medical conditions, age, and socioeconomic status (SES). Individuals who reside in lower SES communities are more likely to experience increased air pollution. The effects of air pollution among those residing in less advantaged communities may be further compounded by reduced access to health care and access to nutrition. Research conducted in our facility and others has established that increased levels of micronutrients can improve subclinical indices of cardiopulmonary disease after acute and chronic air pollution. Omega-3 polyunsaturated fatty acids (PUFAs) have been demonstrated to reduce the markers of cardiopulmonary dysfunction, including heart rate variability, cholesterol, and vascular injury markers after air pollution exposure. However, levels of PUFAs, as well as other potentially protective vitamins, have been demonstrated to be significantly reduced among individuals with lower income and lower educational attainment. This may be in part due to reduced access to healthy food options, as lower income and lower educational attainment have been shown to influence access to grocery stores and nutritious foods.
Given the interplay between nutrition, air pollution exposure, SES, and cardiopulmonary disease, the investigators propose the following study to investigate how socioeconomic status can modify ambient air pollution exposure and subclinical indices of cardiovascular and pulmonary disease and inflammation, and if nutritional status can further modify this relationship. Healthy 25-70-year- old male and female subjects will be recruited from communities that are representative of high and low social vulnerability index, a composite measure of urbanicity, educational attainment, owner-occupied housing, poverty, unemployment, non-managerial occupations, single parent households, houses built since 2000, vehicle ownership, and percentage of people who pay <30% of their income on housing status. Participants will be recruited in the Raleigh-Durham-Cary combined statistical area (CSA) area of North Carolina. Qualified subjects will complete a dietary questionnaire and come to the EPA Human Studies Facility for 3 sessions. The following endpoints will be taken from subjects: blood pressure, heart rate variability (HRV), venous blood, retinal imaging, and spirometry. Blood collected will be assessed for markers of inflammation, oxidative stress, vasoconstriction, coagulation, as well as nutritional status. Air pollution exposure will be assessed for the 24-hour and weeklong period of each visit using area-specific air quality data, provided by stationary air monitors. In addition, participants will be provided with silicone wrist bands to wear for three weeklong intervals during the duration of their study. Silicone wrist bands have been shown to sorb a wide range of volatile and semi-volatile compounds and will serve as a passive personal exposure monitor to air. The investigators hypothesize that residence in a neighborhood with high social vulnerability will increase both personal exposure to air pollution and the associated health effects of air pollution exposure. The investigators further hypothesize that nutrition, specifically components in nutrition demonstrated to be anti-inflammatory, will modulate this relationship and reduce cardiopulmonary outcomes associated with exposure.
- Conditions
- Air Pollution, Pollution; Exposure, Nutrition, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High SVI | Participants reside in neighborhood zip code clusters that rank at the top of the social vulnerability index (most vulnerable) | |
| Low SVI | Participants reside in neighborhood zip code clusters that rank at the bottom of the social vulnerability index (least vulnerable) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability - SDNN
Time-domain measurement: standard deviation of the normal-to-normal (SDNN) in milliseconds
This outcome is measured repeatedly to assess change in HRV associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Heart Rate Variability - rMSSD
Time-domain measurement: root-mean squared of successive differences (rMSSD) in milliseconds
This outcome is measured repeatedly to assess change in HRV associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Heart Rate Variability - LF absolute power
Frequency-domain measurement: Low frequency power (LF, 0.04-0.15 Hz) in ms squared divided by cycles per second (ms2/Hz).
This outcome is measured repeatedly to assess change in HRV associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Heart Rate Variability - VLF absolute power
Frequency-domain measurement: Very Low frequency power (VLF, 0.0033-0.04 Hz) in ms squared divided by cycles per second (ms2/Hz).
This outcome is measured repeatedly to assess change in HRV associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Heart Rate Variability - HF absolute power
Frequency-domain measurement: High frequency power (HF, 0.15-0.40 Hz) in ms squared divided by cycles per second (ms2/Hz).
This outcome is measured repeatedly to assess change in HRV associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Heart Rate Variability - LF/HF power
Frequency-domain measurement: ratio of LF power divided by HF power, expressed as ratio
This outcome is measured repeatedly to assess change in HRV associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Secondary outcomes (16)
Pulmonary Function - FVC
Forced vital capacity (FVC) measured in Liters (L) measured via Sensor Medic Vmax pulmonary function system (dry rolling seal spirometer).
This outcome is measured repeatedly to assess change in lung function associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Pulmonary Function - FEV1
Forced Expiratory Volume in 1 second (FEV1) measured in Liters (L) measured via Sensor Medic Vmax pulmonary function system (dry rolling seal spirometer).
This outcome is measured repeatedly to assess change in lung function associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Pulmonary Function - FEV1/FVC
the ratio of Forced Expiratory Volume in 1 second (FEV1) measured in Liters (L) divided by Forced Vital Capacity (FVC) measured in Liters (L) measured via Sensor Medic Vmax pulmonary function system (dry rolling seal spirometer). Expressed as a percentage
This outcome is measured repeatedly to assess change in lung function associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Peripheral Venous Blood - Total Cholesterol
Total cholesterol measured in plasma in milligrams per deciliter (mg/dL)
This outcome is measured repeatedly to assess change in blood lipids associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Peripheral Venous Blood - HDL
High density lipoproteins measured in plasma in milligrams per deciliter (mg/dL)
This outcome is measured repeatedly to assess change in blood lipids associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Peripheral Venous Blood - LDL
Low density lipoproteins measured in plasma in milligrams per deciliter (mg/dL)
This outcome is measured repeatedly to assess change in blood lipids associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Peripheral Venous Blood - VLDL
Very Low density lipoproteins measured in plasma in milligrams per deciliter (mg/dL)
This outcome is measured repeatedly to assess change in blood lipids associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Peripheral Venous Blood - Triglycerides
Triglycerides measured in plasma in milligrams per deciliter (mg/dL)
This outcome is measured repeatedly to assess change in blood lipids associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Peripheral Venous Blood - CRP
C Reactive Protein measured in plasma in milligrams per deciliter (mg/dL)
This outcome is measured repeatedly to assess change in inflammatory markers associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Peripheral Venous Blood - IL1B
Cytokine IL1B measured in plasma in picograms per milliliter (pg/mL)
This outcome is measured repeatedly to assess change in inflammatory markers associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Peripheral Venous Blood - IL6
Cytokine IL6 measured in plasma in picograms per milliliter (pg/mL)
This outcome is measured repeatedly to assess change in inflammatory markers associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Peripheral Venous Blood - IL8
Cytokine IL8 measured in plasma in picograms per milliliter (pg/mL)
This outcome is measured repeatedly to assess change in inflammatory markers associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Peripheral Venous Blood - TNFa
Cytokine TNFa measured in plasma in picograms per milliliter (pg/mL)
This outcome is measured repeatedly to assess change in inflammatory markers associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Retinal Vasculature - CRAE
Retinal images taken via non-mydriatic fundus camera are analyzed for central retinal artery equivalent (CRAE) measured in micrometer (um)
This outcome is measured repeatedly to assess change in retinal vasculature associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Retinal Vasculature - CRVE
Retinal images taken via non-mydriatic fundus camera are analyzed for central retinal venous equivalent (CRAE) measured in micrometer (um)
This outcome is measured repeatedly to assess change in retinal vasculature associated with change in ambient air pollution exposure
Measured: Through study completion, an average of 1-2 years
Retinal Vasculature - AVR
Retinal images taken via non-mydriatic fundus camera are analyzed for arteriole to venule ratio (AVR), which is central retinal venous equivalent (CRAE) measured in micrometer (um) divided by central retinal artery equivalent (CRAE). Expressed as a ratio T wave complexity
Measured: Through study completion, an average of 1-2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start21 Aug 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Air PollutionStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Environmental Protection Agency (EPA)
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Haiyan Tong, Environmental Protection Agency (EPA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05843370
- Sponsor's protocol ID
- 23-0428
- Acronym
- SENSE
- Status last verified
- Feb 2024
- First submitted
- 24 Mar 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of Ambient Air Pollution Exposure and Cardiopulmonary Outcomes by Socioeconomic Status and Nutrition
- ClinicalTrials.gov ID
- NCT05843370
- Acronym / sponsor ID
- SENSE / 23-0428
- Conditions
- Air Pollution, Pollution; Exposure, Nutrition, Healthy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Environmental Protection Agency (EPA)US federal agency
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 6 May 2023 (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.
The goal of this observational study is to compare the effects of air pollution exposure and nutrition between neighborhoods with high and low social vulnerability scores. The main questions this study aims to answer are:
- Does living in a neighborhood with high or low vulnerability influence the response of the heart, lungs, and immune system to air pollution.
- Does nutritional status alter the association between air pollution exposure and changes in the heart, lungs, and immune system.
Participants (age 25-70 years) that live in neighborhoods ranked high or low on the Social Vulnerability Index (SVI) will take part in 3 visits. Each visit involves the following:
- Measurements of heart activity, lung function, and blood to measure changes that may be caused by air pollution.
- Questionnaires about the types of food eaten and activities that may modify exposure to air pollution.
- Estimation of air pollution exposure using a study iPhone. Participants will carry a study iPhone with them for 24 hours at each visit. The study iPhone runs an application (app) that estimates the amount of air pollution each participant is exposed to.
- Wearing silicone wristbands for a week before each study visit. Silicone wristbands absorb air pollutants and are later measured see the types and amounts of chemicals participants are exposed to.
Detailed description
Acute and chronic exposure to air pollution are well-established risk factors for all-cause mortality, mainly driven by cardiovascular and respiratory disease. The health effects of air pollution exposure have been shown to be mediated by a range of community level and personal factors, including the presence of preexisting medical conditions, age, and socioeconomic status (SES). Individuals who reside in lower SES communities are more likely to experience increased air pollution. The effects of air pollution among those residing in less advantaged communities may be further compounded by reduced access to health care and access to nutrition. Research conducted in our facility and others has established that increased levels of micronutrients can improve subclinical indices of cardiopulmonary disease after acute and chronic air pollution. Omega-3 polyunsaturated fatty acids (PUFAs) have been demonstrated to reduce the markers of cardiopulmonary dysfunction, including heart rate variability, cholesterol, and vascular injury markers after air pollution exposure. However, levels of PUFAs, as well as other potentially protective vitamins, have been demonstrated to be significantly reduced among individuals with lower income and lower educational attainment. This may be in part due to reduced access to healthy food options, as lower income and lower educational attainment have been shown to influence access to grocery stores and nutritious foods.
Given the interplay between nutrition, air pollution exposure, SES, and cardiopulmonary disease, the investigators propose the following study to investigate how socioeconomic status can modify ambient air pollution exposure and subclinical indices of cardiovascular and pulmonary disease and inflammation, and if nutritional status can further modify this relationship. Healthy 25-70-year- old male and female subjects will be recruited from communities that are representative of high and low social vulnerability index, a composite measure of urbanicity, educational attainment, owner-occupied housing, poverty, unemployment, non-managerial occupations, single parent households, houses built since 2000, vehicle ownership, and percentage of people who pay <30% of their income on housing status. Participants will be recruited in the Raleigh-Durham-Cary combined statistical area (CSA) area of North Carolina. Qualified subjects will complete a dietary questionnaire and come to the EPA Human Studies Facility for 3 sessions. The following endpoints will be taken from subjects: blood pressure, heart rate variability (HRV), venous blood, retinal imaging, and spirometry. Blood collected will be assessed for markers of inflammation, oxidative stress, vasoconstriction, coagulation, as well as nutritional status. Air pollution exposure will be assessed for the 24-hour and weeklong period of each visit using area-specific air quality data, provided by stationary air monitors. In addition, participants will be provided with silicone wrist bands to wear for three weeklong intervals during the duration of their study. Silicone wrist bands have been shown to sorb a wide range of volatile and semi-volatile compounds and will serve as a passive personal exposure monitor to air. The investigators hypothesize that residence in a neighborhood with high social vulnerability will increase both personal exposure to air pollution and the associated health effects of air pollution exposure. The investigators further hypothesize that nutrition, specifically components in nutrition demonstrated to be anti-inflammatory, will modulate this relationship and reduce cardiopulmonary outcomes associated with exposure.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High SVI | – | –Participants reside in neighborhood zip code clusters that rank at the top of the social vulnerability index (most vulnerable) |
| Low SVI | – | –Participants reside in neighborhood zip code clusters that rank at the bottom of the social vulnerability index (least vulnerable) |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population represents individuals living in neighborhoods ranked either at the top or bottom of the Social Vulnerability Index, a measure of community vulnerability.
Key inclusion criteria (3 listed)
- Aged 25-70 years old males and females.
- Residing in Zip Code Tabulation Area in Raleigh-Durham great triangle area representing high or low social vulnerability index (SVI).
- Continuous residence at the same address during previous one year.
Key exclusion criteria (22 listed)
- Individuals with a diagnosis of COVID-19 and have persistent symptoms due to that infection (e.g., shortness of breath) or symptoms consistent with "long COVID".
- Individuals not "up to date" on their vaccinations for COVID-19. [which means a person who has received all recommended COVID-19 vaccines, including any booster dose(s) when eligible].
- Individuals who have difficulty to come to the HSF medical station on a weekday for data collection without assistance.
- Individuals have a history of heart arrhythmia, a pacemaker user, been diagnosed with arrhythmia and prescribed a medication to treat arrhythmia.
- Individuals have uncontrolled hypertension (>180 systolic, >110 diastolic)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Heart Rate Variability - SDNN
Time frame: Through study completion, an average of 1-2 years
Time-domain measurement: standard deviation of the normal-to-normal (SDNN) in milliseconds This outcome is measured repeatedly to assess change in HRV associated with change in ambient air pollution exposure
Heart Rate Variability - rMSSD
Time frame: Through study completion, an average of 1-2 years
Time-domain measurement: root-mean squared of successive differences (rMSSD) in milliseconds This outcome is measured repeatedly to assess change in HRV associated with change in ambient air pollution exposure
Heart Rate Variability - LF absolute power
Time frame: Through study completion, an average of 1-2 years
Frequency-domain measurement: Low frequency power (LF, 0.04-0.15 Hz) in ms squared divided by cycles per second (ms2/Hz). This outcome is measured repeatedly to assess change in HRV associated with change in ambient air pollution exposure
Heart Rate Variability - VLF absolute power
Time frame: Through study completion, an average of 1-2 years
Frequency-domain measurement: Very Low frequency power (VLF, 0.0033-0.04 Hz) in ms squared divided by cycles per second (ms2/Hz). This outcome is measured repeatedly to assess change in HRV associated with change in ambient air pollution exposure
Heart Rate Variability - HF absolute power
Time frame: Through study completion, an average of 1-2 years
Frequency-domain measurement: High frequency power (HF, 0.15-0.40 Hz) in ms squared divided by cycles per second (ms2/Hz). This outcome is measured repeatedly to assess change in HRV associated with change in ambient air pollution exposure
Heart Rate Variability - LF/HF power
Time frame: Through study completion, an average of 1-2 years
Frequency-domain measurement: ratio of LF power divided by HF power, expressed as ratio This outcome is measured repeatedly to assess change in HRV associated with change in ambient air pollution exposure
16 secondary outcomes
Pulmonary Function - FVC
Time frame: Through study completion, an average of 1-2 years
Pulmonary Function - FEV1
Time frame: Through study completion, an average of 1-2 years
Pulmonary Function - FEV1/FVC
Time frame: Through study completion, an average of 1-2 years
Peripheral Venous Blood - Total Cholesterol
Time frame: Through study completion, an average of 1-2 years
Peripheral Venous Blood - HDL
Time frame: Through study completion, an average of 1-2 years
Peripheral Venous Blood - LDL
Time frame: Through study completion, an average of 1-2 years
Peripheral Venous Blood - VLDL
Time frame: Through study completion, an average of 1-2 years
Peripheral Venous Blood - Triglycerides
Time frame: Through study completion, an average of 1-2 years
Peripheral Venous Blood - CRP
Time frame: Through study completion, an average of 1-2 years
Peripheral Venous Blood - IL1B
Time frame: Through study completion, an average of 1-2 years
Peripheral Venous Blood - IL6
Time frame: Through study completion, an average of 1-2 years
Peripheral Venous Blood - IL8
Time frame: Through study completion, an average of 1-2 years
Peripheral Venous Blood - TNFa
Time frame: Through study completion, an average of 1-2 years
Retinal Vasculature - CRAE
Time frame: Through study completion, an average of 1-2 years
Retinal Vasculature - CRVE
Time frame: Through study completion, an average of 1-2 years
Retinal Vasculature - AVR
Time frame: Through study completion, an average of 1-2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
Related trials for Air Pollution
Not yet recruiting
Reducing Exposure With Air Cleaners and Technology
Asthma, COPD (Chronic Obstructive Pulmonary Disease)
Recruiting
Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)
Cardiovascular Diseases (CVD), Metabolic Syndrome
Recruiting
Lungs on Fire: Wildfire Smoke, Incident Diseases, Susceptible Populations, and Community Values in Canada
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Recruiting
Air Pollution and Cardiovascular Disease in Qatar: an Interventional Study to Reduce Blood Pressure
Hypertension, Systolic, Metabolic Syndrome
Active, not recruiting
AIRWEIGHS: Investigating Obesity as a Susceptibility Factor for Air Pollution in Childhood Asthma
Asthma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Air Pollution and Pollution; Exposure, run by Environmental Protection Agency (EPA) 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 3 inclusion and 22 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: enrolling by invitation, as of the sponsor's last update on 20 Feb 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
Heart Rate Variability - SDNN (time frame: Through study completion, an average of 1-2 years). The study lists 6 primary outcomes in all. 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 20 Feb 2024.