Particulate Matter, Blood Pressure, and the Sympathetic Nervous System

NCT03079843 | Completed DMC

• 1 other identifier: HUM00122766
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Healthy volunteers will be exposed to ambient air near a roadway under the conditions of with and without a facemask and their responses will be evaluated.

Conditions

Air Pollution

Outcome Measures

Primary Outcomes (1)

• blood pressure

  increased blood pressure as a result of air pollution exposure without the mask.

  one week

Study Arms (2)

facemask first then no face mask

EXPERIMENTAL

wearing of mask each day for the two hours of exposure for the first week of exposure then not wearing the mask each day for the two hours of exposure for the second week of exposure

Other: exposure to particulate matter with N 95 facemask; Other: exposure to particulate matter with no face mask

no face mask followed by wearing face mask

EXPERIMENTAL

not wearing the mask each day for the two hours of exposure for the first week of exposure then wearing the mask each day for the two hours of exposure for the second week of exposure

Other: exposure to particulate matter with N 95 facemask; Other: exposure to particulate matter with no face mask

Interventions

exposure to particulate matter with N 95 facemask OTHER

2 hours' / day exposure to particulate matter face mask worn during exposure.

Also known as: Dettol PROTECT+ Smart Mask

facemask first then no face mask; no face mask followed by wearing face mask

exposure to particulate matter with no face mask OTHER

2 hours'/ day exposure to particulate matter with no face mask

facemask first then no face mask; no face mask followed by wearing face mask

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age 18-65 years old. People older than 65 years are excluded as the impact of PM2.5 on their BP is not known from our prior studies (which included younger individuals) and they have age-related increases in BP and SNS activity which may alter their associations with PM2.5 exposures and thus produce too heterogeneous a population to evaluate the linkages between PM2.5 and health outcomes.
• \. Self-reported nonsmoker (100% abstinence for at least 1 year) living in non-smoking households (no one living in the household that smokes indoors) and no known routine exposures to air pollutants by known point sources at home, travel or occupationally (e.g., fumes, dust, secondhand smoke). Smoking and other exposures may alter any effect that ambient PM2.5 has on the health outcomes.
• \. Able to understand the informed consent, legally provide informed consent, and able to participate for the entire duration of the study.

You may not qualify if:

• \. Any facial hair (beard or mustache) that does not allow for proper fitting and air tight seal of the N95 facemask during the study that would compromise the ability of the mask to prevent exposures.
• \. Any prior cardiovascular diseases (coronary artery disease (CAD), congestive heart failure (CHF), stroke, peripheral arterial disease (PAD), aneurysms, any revascularization)\*
• \. Prior diagnosis of hypertension, diabetes, sleep apnea\*
• \. Prior diagnosis of chronic lung diseases (asthma, chronic obstructive lung disease (COPD))\*
• \. Prior diagnosis of neurological disorders (Parkinson's disease, autonomic failure, peripheral neuropathy, seizure disorder) or other conditions at discretion of investigators\*
• \. Prior diagnosis of chronic kidney disease, any type of dialysis\*
• \. Active or history of any known cancer\*
• \. History of HIV\*
• \. Being treated for any infection with antibiotics within past month\*
• \. Mental health issue(s) including anxiety disorders, mood disorders, schizophrenia, or other conditions at discretion of investigators\*
• \. Prior diagnosis of any other chronic or acute medical condition(s) at discretion of investigators that may lead to alteration of baseline SNS activity, BP, or insulin sensitivity and thereby potentially impact the association of PM2.5 with study outcomes.
• \. Medications for high BP or that alter BP. Any medications for cholesterol (e.g., statins). Any medications that alter blood glucose (e.g., diabetes medication)\*.
• \. Screening visit BP ≥140/90 mm Hg (as measured by the automated office BP device- BpTru)
• \. Screening visit arm circumference ≥17 inches (makes home BP monitoring inaccurate as the cuff of the commercially-available devices will not fit).
• \. Screening visit pregnancy (positive urine pregnancy test in women \<50 years of age) and any plan to become pregnant during the study period

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48103, United States

Location

Study Officials

• Robert Brook, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 10, 2017
• First Posted: March 15, 2017
• Study Start: April 7, 2017
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: May 2, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)