Effects of Low Dose Ozone on Airway Inflammatory Responses in Adults With Asthma - Sedentary Nasal Ozone (Asthma SNOZ)
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Asthma, Allergic
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Crossover AssignmentMasking: Double (Participant, Investigator)Primary Purpose: Basic Science
Participation Requirements
- Age
- Between 18 years and 45 years
- Gender
- Both males and females
Description
Short-term exposure to ambient air ozone has been recognized for decades to be adversely associated with impacts on the respiratory system. Indeed the evidence is such that the Environmental Protection Agency (EPA) has determined that there is a causal relationship, and even lowered the 8-hour expos...
Short-term exposure to ambient air ozone has been recognized for decades to be adversely associated with impacts on the respiratory system. Indeed the evidence is such that the Environmental Protection Agency (EPA) has determined that there is a causal relationship, and even lowered the 8-hour exposure standard to 0.07 parts per million (ppm) in 2015. Controlled human exposure studies and epidemiological studies have consistently observed ozone-associated decrements in lung function and increased respiratory symptoms. Most controlled human exposure studies have been performed with high ozone concentrations. Additionally, epidemiologic studies have focused on populations engaged in outdoor activities (increasing ozone exposure through increased minute ventilation), or in cities such as Los Angeles or Mexico City where ambient ozone levels are especially high. Evidence has recently emerged that exposure to low ozone concentrations also produces adverse health effects, especially among susceptible groups including children with asthma. The University of North Carolina - North Carolina State University (UNC-NCSU) ASSIST group is examining the use of wearable technology that can measure levels of environmental pollutants and changes in physiologic parameters as potential adjuncts to the management of asthma. In ambient air, ozone (O3) is the most commonly encountered environmental trigger for asthma exacerbation, even at levels below the EPA standards of 0.120 ppm (1-hour average) and 0.07 ppm (8-hour average). Environmental sensors that can monitor ozone exposure have been proposed to help high-risk patients avoid potential asthma triggers. The HET tracker has been proposed as one such system to provide personalized monitoring of ozone exposure. However, because devices that are based on user preferences are more likely to be adopted and used, data are needed on user experiences and preferences with wearable technology. It is also well established that poor symptom perception can reduce a patient's ability to recognize when their symptoms are worsening, thereby, decreasing the probability that they would take prophylactic action that could prevent further symptom progression and subsequent exacerbations. The negative impacts of asthma are largely preventable if patients engage in self-management behaviors, including symptom monitoring. The autonomic nervous system regulates physiologic responses like bronchoconstriction and mucus production, as well as heart rate (HR), heart rate variability (HRV) and respiratory rate (RR): all can be monitored continuously in daily life using wearable sensors. As an exploratory aim, the investigators wish to identify the capability of the HET devices to sense physiologic changes (suggestive of changes in autonomic tone, such as HRV) compared to gold standard monitors used in clinical practice. As part of the National Science Foundation (NSF) Nanosystems Engineering Research Center for Advanced Self-Powered Systems of Integrated Sensors and Technologies (ASSIST) Center, engineers at NCSU have been developing non-commercial technologies for achieving a high-performance and multi-functional biomedical sensing system while minimizing power consumption. The UNC-NC State ASSIST partnership developed the Health and Environmental Tracker (HET) testbed as a wireless ultra-low power system for correlated sensing of multiple environmental and health parameters. The objective of this study is to examine if low level ozone exposure (compared to a clean air exposure), reflective of a typical metropolitan summer day, will cause decrements in lung function and measurable upper and lower airway inflammation in mild asthmatics (who are not on asthma controller medications) while performing typical daily activities.
Tracking Information
- NCT #
- NCT04109807
- Collaborators
- Environmental Protection Agency (EPA)
- North Carolina State University
- Investigators
- Principal Investigator: Michelle Hernandez, MD UNC SOM