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NCT05843370

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

Enrolling by Invitation
Not specifiedAges 25–70Observational
Environmental Protection Agency (EPA)
~82 participants
Updated 2024-02-20 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Heart Rate Variability - SDNN
Measured over Through study completion, an average of 1-2 years
+5 more outcomes measured

Conditions

Air Pollution
Pollution; Exposure
Nutrition, Healthy

Explore related trials

Cardiopulmonary Health

Where it's being run

1 sites across 1 states
North Carolina1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.
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.
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.

What this trial measures

  • Heart Rate Variability - SDNNThrough 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 - rMSSDThrough 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 powerThrough 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 powerThrough 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 powerThrough 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 powerThrough 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