Modification of Ambient Air Pollution Exposure and Cardiopulmonary Outcomes by Socioeconomic Status and Nutrition

NCT05843370 | Enrolling By Invitation

• 1 other identifier: 23-0428
• Study Type: observational
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Air Pollution; Pollution; Exposure; Nutrition, Healthy

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

  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

  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

  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

  Through study completion, an average of 1-2 years

Secondary Outcomes (16)

• Pulmonary Function - FVC

  Through study completion, an average of 1-2 years

• Pulmonary Function - FEV1

  Through study completion, an average of 1-2 years

• Pulmonary Function - FEV1/FVC

  Through study completion, an average of 1-2 years

• Peripheral Venous Blood - Total Cholesterol

  Through study completion, an average of 1-2 years

• Peripheral Venous Blood - HDL

  Through study completion, an average of 1-2 years

Other Outcomes (1)

• Concentration of Air Toxics via Silicone Wrist Band

  Through study completion, an average of 1-2 years

Study Arms (2)

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)

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Environmental Protection Agency (EPA): lead

Study Sites (1)

EPA Human Studies Facility

Chapel Hill, North Carolina, 27514, United States

Location

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: May 6, 2023
• Study Start: August 21, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

US (1)