- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07629518
Democratizing Access to Cleaner Residential Air (DACRA)
Study Overview
Status
Conditions
Detailed Description
Conduct a randomized crossover pilot trial with 66 participants to calculate preliminary effect size estimates to inform a larger crossover efficacy trial:
We will: 1) enroll 66 individuals living in low and high traffic areas in Hartford (N=44) and a highly polluted urban areas in Boston Chinatown (N=22); and 2) install full filtration DIYAPs and sham DIYAPs for 30 days each in a randomized crossover trial design with a 14-day wash-out in between; and 3) measure seated and ambulatory BP, administer the SF-12v2, the Trail Making Test Part B, collect blood, and measure both indoor and outdoor PM (in size bins).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Doug Brugge, PhD
- Phone Number: 18606748814
- Email: brugge@uchc.edu
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Age 40 years or older Speaks English, Vietnamese, and/or Chinese Cognitive capacity to respond to questionnaires Lives fulltime at the current address, adjacent (< 200 meters) to roadways with large traffic volumes Must have one or more risk factors (hypertension or elevated blood pressure, pre-diabetes or diabetes or elevated blood sugar levels, elevated cholesterol levels, body mass index 25 or greater)
Exclusion Criteria:
Pregnant Works between the hours of 10 PM and 6 AM Sources of smoke in the living space (such as candles, incense, marijuana, wood stove, fireplace) almost every day/every day.
Every day exposure to motor vehicle exhaust (from cars, trucks, buses, trains), including heavy street or highway traffic.
Currently smoking or vaping Others smoking or vaping indoors, in the living space. Within the past 5 years, a diagnosis of heart attack, heart disease, stroke, blood clots or pulmonary embolism, cancer requiring surgery and/or chemo/radiation therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Active filtration
Air purifiers with HEPA filters
|
Portable air purifiers filter air and reduce exposure to air pollutants, in this case, airborne particulate matter
|
|
Sham Comparator: Sham filtration
Air purifiers lacking HEPA filters
|
Air purifiers with filters removed (sham)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Blood pressure
Time Frame: Day 0, 30, 45, and 75
|
Periferal blood pressure, seated
|
Day 0, 30, 45, and 75
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
IL-1beta
Time Frame: Day 0, 30, 45, and 75
|
Blood inflammatory biomarker
|
Day 0, 30, 45, and 75
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Doug M Brugge, UConn Health
Study record dates
Study Major Dates
Study Start (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-285-2
- R34HL173375 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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