NCT06534385

Brief 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. 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 2, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

November 25, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 27, 2025

Status Verified

February 1, 2025

Enrollment Period

1.3 years

First QC Date

July 30, 2024

Last Update Submit

February 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Indoor particulate matter (PM2.5) concentrations

    Mean weekly home indoor particulate matter (PM2.5) concentrations

    12-weeks

Secondary Outcomes (1)

  • Reported symptom-free days

    12-weeks

Study Arms (1)

Single group

EXPERIMENTAL

Participants receive HEPA purifiers and air monitoring equipment to operate daily for 12-weeks.

Device: Air purifier

Interventions

Winix HEPA air purifier

Single group

Eligibility Criteria

AgeUp to 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Alaska Native participants residing in homes where woodstoves are used for heat or a smoker resides in the home.

You may not qualify if:

  • Plan to move homes during the study period.
  • Using HEPA air purifiers (other than the ones provided by the study).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yukon Kuskowkim Health Corporation

Bethel, Alaska, 99559, United States

RECRUITING

MeSH Terms

Interventions

Air Filters

Intervention Hierarchy (Ancestors)

FiltrationChemistry Techniques, AnalyticalInvestigative TechniquesEquipment and Supplies

Central Study Contacts

Jennifer Dobson, MPH

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2024

First Posted

August 2, 2024

Study Start

November 25, 2024

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

February 27, 2025

Record last verified: 2025-02

Locations