Air Pollution, IndoorNCT06534385
The Clean Air Study: HEPA Purifiers to Improve Indoor Air Quality and Health in Rural Alaska Homes
A study testing Air purifier in people with Air Pollution, Indoor, run by Alaska Native Tribal Health Consortium at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 5 yearsHealthy volunteers can take part
- Conditions the study is for
- Air Pollution, Indoor
- What is being tested?
- Air purifier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Alaska Native participants residing in homes where woodstoves are used for heat or a smoker resides in the home.
Who cannot join
- Plan to move homes during the study period.
- Using HEPA air purifiers (other than the ones provided by the study).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yukon Kuskowkim Health Corporation
Bethel, Alaska, 99559
About this study
Official title: 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.
Read more
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.
Read the detailed description
When a child has a pulmonology visit, the nurse will give the family a study flyer and invite them to learn more about the study. Participants that complete the informed consent process will be asked to: set up study equipment in their homes, operate the study equipment and do a weekly report of the child's respiratory symptoms for 12 weeks, and return the air monitoring equipment to the study team.
- Conditions
- Air Pollution, Indoor
- Being tested
- Air purifier
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Air purifierDevice
Winix HEPA air purifier
| Study group | Role | What they receive |
|---|---|---|
| Single group | Experimental | Participants receive HEPA purifiers and air monitoring equipment to operate daily for 12-weeks. Receives: Device: Air purifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
Indoor particulate matter (PM2.5) concentrations
Mean weekly home indoor particulate matter (PM2.5) concentrations
Measured: 12-weeks
Secondary outcomes (1)
Reported symptom-free days
paired analysis of mean symptom-free days with no reported respiratory symptoms
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start25 Nov 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Air Pollution, IndoorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alaska Native Tribal Health Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06534385
- Sponsor's protocol ID
- 1P20GM152302-01
- Status last verified
- Feb 2025
- First submitted
- 30 Jul 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clean Air Study: High Efficiency Particulate Air (HEPA) Purifiers to Improve Indoor Air Quality and Health in Rural Alaska Homes
- ClinicalTrials.gov ID
- NCT06534385
- Acronym / sponsor ID
- 1P20GM152302-01
- Conditions
- Air Pollution, Indoor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Alaska Native Tribal Health ConsortiumUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
When a child has a pulmonology visit, the nurse will give the family a study flyer and invite them to learn more about the study. Participants that complete the informed consent process will be asked to: set up study equipment in their homes, operate the study equipment and do a weekly report of the child's respiratory symptoms for 12 weeks, and return the air monitoring equipment to the study team.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | Experimental | Device: Air purifierParticipants receive HEPA purifiers and air monitoring equipment to operate daily for 12-weeks. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Alaska Native participants residing in homes where woodstoves are used for heat or a smoker resides in the home.
Key exclusion criteria (2 listed)
- Plan to move homes during the study period.
- Using HEPA air purifiers (other than the ones provided by the study).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Air purifierWinix HEPA air purifier | Device | Single group |
Primary outcome
Indoor particulate matter (PM2.5) concentrations
Time frame: 12-weeks
Mean weekly home indoor particulate matter (PM2.5) concentrations
1 secondary outcome
Reported symptom-free days
Time frame: 12-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Air purifier in people with Air Pollution, Indoor, run by Alaska Native Tribal Health Consortium at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Dobson, MPH (9075453241, jddobson@anthc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Indoor particulate matter (PM2.5) concentrations (time frame: 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.