ASPIRE Health Tulare County

NCT05944770 | Unknown

• 1 other identifier: 23-0965
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare indoor air quality and health in people exposed to air pollution, including possible exposure to wildfire smoke. The study will test the effect of using a do-it-yourself (DIY) air cleaner when air pollution is present to answer the following questions:

• Do health outcomes differ between participants who use a DIY PAC and those who use a sham air cleaner?
• How effective is the DIY air cleaner in reducing indoor concentrations of fine particles (PM2.5), and volatile organic compounds found in wildfire smoke? OR How effective is the DIY air cleaner in reducing indoor concentrations of fine and coarse particles (i.e., PM 10)?
• What are barriers to use of a DIY air cleaner and what factors facilitate its use? Participants will be asked to do the following:
• Participate in 5 home visits from study staff between July - October 2023
• Have an air quality sensor placed in the participant's bedroom for the whole study period
• Have a small sensor attached to the main door of the participant's house to record when the door is open or closed (important for air quality inside)
• Allow researchers to take air and dust samples in the participant's bedroom
• Run a DIY air cleaner in the participant's bedroom for at least 6 nights while the participant sleeps
• Complete 2 interviews
• Allow study staff to collect 3 fingerstick blood samples
• Allow study staff to collect 3 samples of fluid from inside the nose
• Use the study air cleaner in the participant's bedroom during the study period The investigators will measure air quality in participating homes and measure health outcomes for participants. The investigators will compare outcomes of participants who use a DIY air cleaner with filters that work well to those of participants who use a DIY air cleaner with a placebo filter (one that does not work well to remove the air pollutants of concern). The goal of the study is to see if using the effective air cleaner leads to better health outcomes and indoor air quality.

Conditions

Respiratory Tract Diseases; Cardiovascular Diseases

Keywords

air pollution; wildfire smoke; wildland fire smoke; air filtration; indoor air quality

Outcome Measures

Primary Outcomes (1)

• Difference in change in concentrations of biomarkers of inflammation between treatment and control groups

  Markers of inflammation include C-reactive protein obtained from fingerstick blood samples

  Measured at baseline (pre-intervention) and at two timepoints, at least 3 days apart, during the portable air cleaner usage period (intervention)

Secondary Outcomes (2)

• Difference in change in concentrations of biomarkers of inflammation between treatment and control groups

  Measured at Baseline and at two timepoints, at least 3 days apart, during the portable air cleaner usage period (intervention)

• Symptom data

  At baseline and at one timepoint during portable air cleaner use

Other Outcomes (1)

• air quality measurements

  Continuous measurement lasting up to 15 weeks

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

Subjects in the treatment arm will use a DIY portable air cleaner made by attaching a highly effective furnace filter (MERV 13) and carbon absorbent to a box fan.

Other: DIY portable air cleaner with a highly effective filter

Control arm

SHAM COMPARATOR

Subjects in the control arm will use a DIY portable air cleaner with a sham filter. All subjects will receive education on air quality, wildfire smoke, and health.

Other: DIY portable air cleaner with sham filtration

Interventions

DIY portable air cleaner with a highly effective filter OTHER

A portable air filtration device that can be homemade ("DIY"), constructed by attaching a highly effective air filter (MERV13 rating or higher) to a 20 inch box fan to filter air pollutants including particulate matter of size 2.5 micrometers diameter or greater.

Intervention arm

DIY portable air cleaner with sham filtration OTHER

A portable air filtration device that can be homemade ("DIY") by attaching an air filter to a 20 inch box fan. The portable air cleaner with sham filtration with have a filter that is not effective for filtration of fine particulate matter, including that in wildfire smoke.

Control arm

Eligibility Criteria

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

You may qualify if:

• Age 18 years or older
• Has access to telephone and/or the internet for study communication
• Is a resident of Tulare County, California
• Is proficient in English or Spanish for study communication

You may not qualify if:

• Anyone in the household smokes (tobacco, vape, or other) inside the home
• Plans to move before November 2023
• Regularly travels or sleeps away from home (e.g., once a week or more)
• Already owns and uses a portable air cleaner
• Lives in a multi-unit home with a shared central HVAC system
• Has a bleeding disorder, such as hemophilia (taking a blood thinning medication does not exclude)
• Takes any of the following anti-inflammatory medications regularly: abatacept (Orencia), adalimumab(Humira), anakinra (Kineret), anifrolumab (Saphnelo), apremilast (Otezla), azathioprine (Imuran),certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi Aria), hydroxychloroquine(Plaquenil), infliximab (Remicade), ixekizumab (Taltz), leflunomide (Arava), methotrexate(Rheumatrex, Trexall), prednisone (Deltasone), sulfasalazine (Azulfidine), rituximab (Rituxan,MabThera), sarilumab (Kevzara), tocilizumab (Actemra)

Sponsors & Collaborators

• Environmental Protection Agency (EPA): lead
• University of North Carolina, Chapel Hill: collaborator

Study Sites (1)

Central California Environmental Justice Network

Fresno, California, 93727, United States

Location

Related Publications (8)

• Cascio WE. Wildland fire smoke and human health. Sci Total Environ. 2018 May 15;624:586-595. doi: 10.1016/j.scitotenv.2017.12.086. Epub 2017 Dec 27.

  PMID: 29272827 BACKGROUND

• 2. U.S. Environmental Protection Agency. Create a Clean Room to Protect Indoor Air Quality During a Wildfire. 2022; https://www.epa.gov/indoor-air-quality-iaq/create-clean-room-protect-indoor-air-quality-during-wildfire. Accessed September 30, 2022.

  BACKGROUND

• Cheek E, Guercio V, Shrubsole C, Dimitroulopoulou S. Portable air purification: Review of impacts on indoor air quality and health. Sci Total Environ. 2021 Apr 20;766:142585. doi: 10.1016/j.scitotenv.2020.142585. Epub 2020 Sep 30.

  PMID: 33121763 BACKGROUND

• 4. Program CTAQ. Box fan filter, a DIY users guide. 2022; https://www.cct-enr.com/box-fan-filter. Accessed September 16, 2022.

  BACKGROUND

• 5. Puget Sound Clean Air Agency. DIY Air Filter. https://pscleanair.gov/525/DIY-Air-Filter. Accessed September 16, 2022.

  BACKGROUND

• Srikrishna D. Can 10x cheaper, lower-efficiency particulate air filters and box fans complement High-Efficiency Particulate Air (HEPA) purifiers to help control the COVID-19 pandemic? Sci Total Environ. 2022 Sep 10;838(Pt 1):155884. doi: 10.1016/j.scitotenv.2022.155884. Epub 2022 May 14.

  PMID: 35580674 BACKGROUND

• Holder AL, Halliday HS, Virtaranta L. Impact of do-it-yourself air cleaner design on the reduction of simulated wildfire smoke in a controlled chamber environment. Indoor Air. 2022 Nov;32(11):e13163. doi: 10.1111/ina.13163.

  PMID: 36437679 BACKGROUND

• Batterman S, Du L, Mentz G, Mukherjee B, Parker E, Godwin C, Chin JY, O'Toole A, Robins T, Rowe Z, Lewis T. Particulate matter concentrations in residences: an intervention study evaluating stand-alone filters and air conditioners. Indoor Air. 2012 Jun;22(3):235-52. doi: 10.1111/j.1600-0668.2011.00761.x. Epub 2012 Feb 4.

  PMID: 22145709 BACKGROUND

Related Links

• Create a clean room to protect indoor air quality during a wildfire

MeSH Terms

Conditions

Respiratory Tract Diseases; Cardiovascular Diseases

Study Officials

• Ann N Chelminski, MD, MPH

  Environmental Protection Agency (EPA)

  PRINCIPAL INVESTIGATOR

• Nayamin Martinez, MPH

  Central California Environmental Justice Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The control air filtration device will have a filter that looks like the intervention filter but is much less effective. A cover "shroud" will be placed over the air filtration device so that differences in components will not be noticeable to participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized to the intervention or control group.

Study Record Dates

• First Submitted: May 31, 2023
• First Posted: July 13, 2023
• Study Start: July 29, 2023
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)