- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06534385
The Clean Air Study: HEPA Purifiers to Improve Indoor Air Quality and Health in Rural Alaska Homes
The Clean Air Study: High Efficiency Particulate Air (HEPA) Purifiers to Improve Indoor Air Quality and Health in Rural Alaska Homes
Alaska Native children experience a high burden of respiratory disease, especially those in the Yukon-Kuskokwim (YK) Delta. Studies have shown that things like wood stove use, poor ventilation, and indoor tobacco smoke exposure can lead to poor indoor air quality inside the children's homes. This leads to more frequent and more severe respiratory infections in children.
In the Yukon-Kuskokwim (YK) Delta, it's common for homes to have exposure to woodstoves and tobacco use. Both of these activities affect indoor air quality in homes. We know that high efficiency particulate air (HEPA) purifiers can reduce particulate matter and make air quality better. One way that we measure air quality is through particulate matter (PM2.5). One of the few studies that looked at this in the YK Delta found that PM2.5 levels that were nearly twice as high as homes with woodstoves in other states. We believe it is important to reduce the PM2.5 in YK Delta homes. However, the few studies that looked at HEPA purifiers in rural Alaska did not include homes where smokers lived.
We know that breathing air with PM2.5 harms the lungs. We also know that HEPA filters can reduce PM2.5, which can mean reducing cough and wheeze in people with chronic lung conditions. We want to learn how HEPA filters work in homes with woodstoves or where a smoker lives, as it's likely these homes may have more PM2.5 than other homes. We expect that using HEPA filters will make the indoor air better and will mean decreased respiratory symptoms.
We plan to include 15 households with a child less than 5 years old in the family. Households that join will be asked to:
- Set up study equipment in their homes.
- Run the study equipment for 12 weeks and do a weekly report of child's respiratory symptoms by phone or text.
- Return the air-quality monitor equipment to the study team and keep the HEPA filters.
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jennifer Dobson, MPH
- Phone Number: 9075453241
- Email: jddobson@anthc.org
Study Locations
-
-
Alaska
-
Bethel, Alaska, United States, 99559
- Recruiting
- Yukon Kuskowkim Health Corporation
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Alaska Native participants residing in homes where woodstoves are used for heat or a smoker resides in the home.
Exclusion Criteria:
- Plan to move homes during the study period.
- Using HEPA air purifiers (other than the ones provided by the study).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Single group
Participants receive HEPA purifiers and air monitoring equipment to operate daily for 12-weeks.
|
Winix HEPA air purifier
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Indoor particulate matter (PM2.5) concentrations
Time Frame: 12-weeks
|
Mean weekly home indoor particulate matter (PM2.5)
concentrations
|
12-weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reported symptom-free days
Time Frame: 12-weeks
|
paired analysis of mean symptom-free days with no reported respiratory symptoms
|
12-weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1P20GM152302-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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