Reducing Particulate Matter-associated Cardiovascular Health Effects for Seniors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
Exposure to fine particulate matter (PM2.5) air pollution is an established risk factor for cardiovascular (CV) morbidity.
详细描述
This is a randomized double-blind placebo-controlled (sham filtration) crossover trial comparing the effectiveness bedroom-only portable indoor air filtration units [AFUs] to reduce personal PM2.5 exposures and improve cardiometabolic health. The health benefits (primary outcome: resting BP) will be evaluated over acute (4-day) and long-term (4-week) periods in 50 nonsmoking elderly adults living in a senior facility impacted by near-roadway pollutants.
Because of COVID-19 restrictions that occurred during the trial, certain outcome measures were removed from the protocol, as they could not be performed: 24-hr Blood Pressure, Heart Rate Variability (HRV), BpTRU BP measurements, and WatchPAT. Other outcome measures were not removed from the protocol, but data could not be collected for them because of COVID restrictions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
filtration units with or without filters. filters are placed by research assistant from the environmental college and researchers performing the health outcomes are blinded to the condition (sham or active filtration) along with the subject.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Nonsmoker
- •≥60 years old
- •residing in Carpenter Place Apartments
排除标准
- •Active cigarette smoker
- •daily secondhand smoke exposure (self-report)
- •any CV event (myocardial infarction, stroke, heart failure, revascularization) in the past 3 months
- •unstable CV condition or risk factor (uncontrolled diabetes, class 3-4 angina or heart failure) or any medical condition that would place the participant at risk from participation or jeopardize study integrity (per investigators)
- •expected overnight travel outside their apartment during the 14-week study period
- •unable to provide informed consent
- •lung disease requiring oxygen
- •renal dialysis
- •cancer receiving active treatment or chemotherapy
- •severe uncontrolled high BP ≥160/100 mm Hg or SBP<115 mm Hg.
- •CV medication change in the prior month. If participants are on medications for high BP, diabetes, or a CV condition, they will need to have stable therapy during the prior month with no planned changes during the study period.
研究组 & 干预措施
air filtration with hepa filter
air purifier used is the Holmes HAP8650B-NU-1 with the hepa filter inserted.
干预措施: air filtration with air purifier with hepa filter (Other)
air filtration with hepa filter removed
sham comparator uses the Holmes HAP8650B-NU-1 air purifier to be operated with the filter removed.
干预措施: sham (Other)
结局指标
主要结局
Systolic Blood Pressure
时间窗: 10 weeks
Systolic blood pressure was measured twice a day, in the morning and the evening, from Tuesday through Friday during the first and fourth week of each of the four-week periods in which participants were exposed to one of the interventions. Results reflect the average of systolic readings taken.
次要结局
- Diastolic Blood Pressure(10 weeks)
- Atmospheric Particulate Matter (pm2.5) - Indoor(10 weeks)
- Atmospheric Particulate Matter (pm2.5) - Outdoor(10 weeks)
- 24-hr Personal PM2.5 (Filter-gravimetric Mass)(2 days)
- Black Carbon, Hourly Personal PM2.5 Levels(10 weeks)
- Aortic Hemodynamics(10 weeks)
- Insulin Sensitivity(10 weeks)
- Adrenal Steroid Panel(10 weeks)
研究者
Geoffrey Barnes
Professor of Internal Medicine
University of Michigan