Viewing Study NCT06534385



Ignite Creation Date: 2024-10-26 @ 3:36 PM
Last Modification Date: 2024-10-26 @ 3:36 PM
Study NCT ID: NCT06534385
Status: NOT_YET_RECRUITING
Last Update Posted: None
First Post: 2024-07-30

Brief Title: The Clean Air Study HEPA Purifiers to Improve Indoor Air Quality and Health in Rural Alaska Homes
Sponsor: None
Organization: None

Study Overview

Official Title: The Clean Air Study High Efficiency Particulate Air HEPA Purifiers to Improve Indoor Air Quality and Health in Rural Alaska Homes
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-07
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 childrens homes This leads to more frequent and more severe respiratory infections in children

In the Yukon-Kuskokwim YK Delta its 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 PM25 One of the few studies that looked at this in the YK Delta found that PM25 levels that were nearly twice as high as homes with woodstoves in other states We believe it is important to reduce the PM25 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 PM25 harms the lungs We also know that HEPA filters can reduce PM25 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 its likely these homes may have more PM25 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 childs 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 childs respiratory symptoms for 12 weeks and return the air monitoring equipment to the study team

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None