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NCT04279249 · ClinicalTrials.gov registry record · NA
Home Air Filtration for Traffic-Related Air Pollution
A NA study of Blood Pressure and Cardiovascular Risk Factor, sponsored by UConn Health.
- Completed
- Registry status
- NA
- Development phase
- 156
- Enrollment target
- 1
- Study location
NCT04279249: Completed NA study of Blood Pressure and Cardiovascular Risk Factor, sponsored by UConn Health.
NCT04279249 is a NA study of Blood Pressure and Cardiovascular Risk Factor that has completed, run by UConn Health. The registered enrollment target is 156 participants, below the 285-participant average among 101 other Blood Pressure trials with a reported enrollment target (45% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04279249, a NA study of Blood Pressure and Cardiovascular Risk Factor, has completed, sponsored by UConn Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 156 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is a blinded randomized crossover efficacy trial (N=172 households consisting of 207 participants) of High Efficiency Particulate Air (HEPA) filtration in near-highway homes that lack mechanical air-handling systems. Households will be randomized to 30 days of either filtration or sham filtration followed by a 30 washout period with a subsequent 30-day period of the alternative assignment. Room air filters that are commercially available will be placed in the bedroom and living room of each home. The investigators will measure UFP and PM2.5 concentrations in 20% of the homes during filtration and sham periods and assess personal exposure in a subset of participants. The investigators will also assess chemical composition of particulate air pollution in 10 homes/year for exploratory purposes that could lead to future lines of research. The primary health endpoints will be participants' hsCRP and peripheral blood pressure, measures that the investigators have used in multiple observational studies of UFP as well as in pilot filtration intervention studies. Secondary biological measures that contribute to understanding biological pathways will be IL-6 (inflammation), D-dimer (coagulation), metabolome, central pressure and arterial stiffness. The primary intention to treat analysis will compare outcomes between HEPA filtration to sham filtration. The investigators will have 80% power to detect a difference of 0.6 mg/L in change in hsCRP and a difference in reduction in systolic blood pressure of 3.5 mmHg compared to participants who receive no filtration. Having participants serve as their own controls in the within-subject comparisons of intervention effectiveness increases statistical power and eliminates the possibility of baseline imbalances in demographic and clinical characteristics. A social science evaluation will inform final adjustments to the investigators' approach at the start and also assess participant acceptance and experience with the interv
Primary Outcome
Seated blood pressure measured using ambulatory monitors
Conditions Studied
Interventions
- OTHER HEPA Air Filtration
- OTHER Sham HEPA Air Filtration
Study Locations (1)
Connecticut
- UConn Health - Farmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2020-11-15 |
| Est. Completion | 2024-06-30 |
| Phase | NA |
What the finished NCT04279249 record still lists
NCT04279249 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, below the 285-participant average among 101 other Blood Pressure trials with a reported enrollment target (45% lower).
The record links to 2 conditions, with Blood Pressure appearing as the primary indexed condition, and to 2 interventions - of which HEPA Air Filtration is the first listed.
NCT04279249 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT04279249 about?
NCT04279249 is a clinical study titled "Home Air Filtration for Traffic-Related Air Pollution". This study is a blinded randomized crossover efficacy trial (N=172 households consisting of 207 participants) of High Efficiency Particulate Air (HEPA) filtration in near-highway homes that lack mechanical air-handling systems. Households will be randomized to 30 days of either filtration or sham fi...
What is the current status of trial NCT04279249?
This trial is currently completed. It is a NA study. The enrollment target is 156 participants. The study started on 2020-11-15. Estimated completion is 2024-06-30.
What conditions does trial NCT04279249 study?
This clinical trial studies the following conditions: Blood Pressure, Cardiovascular Risk Factor.
What interventions are being tested in trial NCT04279249?
The interventions under investigation include: HEPA Air Filtration (OTHER), Sham HEPA Air Filtration (OTHER).
Who is sponsoring clinical trial NCT04279249?
This trial is sponsored by UConn Health, which has 178 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04279249 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04279249's enrollment target sits among peer trials
156 28th of 101 higher than 74 of 101 other Blood Pressure trials
participants (enrollment target), bucketed by value
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