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Particulate Matter, Blood Pressure, and the Sympathetic Nervous System (PM-SNS)

2019年4月30日 更新者:Robert Brook、University of Michigan

Particulate Matter, Blood Pressure, and the Sympathetic Nervous System: Impact of Near-roadway Exposures and N-95 Facemasks

Healthy volunteers will be exposed to ambient air near a roadway under the conditions of with and without a facemask and their responses will be evaluated.

研究概览

详细说明

The investigators will enroll 50 healthy nonsmoking adults (20-65 years old) into a protocol involving 2 separate 5 day long "study blocks". Each block will consist of 5 separate 2 hour-long "exposure periods" conducted 5 days in a row (Monday - Friday; start: 8 am to end: 10 am) (Table 2: Study flow chart). Investigators will enroll 2 patients to undergo the trial study blocks simultaneously (one subject starting block 1 in the active intervention by wearing the facemask and the other wearing no facemask to begin block 1). Day 1 (Monday) of each study block will occur in a non-polluted clean indoor setting (Research Exam Room, Suite A 1310; Lobby A, Dominos Farms). All subsequent exposure periods (days 2-5, Tuesday through Friday) of each study block will all take place at the same designated "exposure site", an Ann Arbor Transportation Association (AATA) parking lot area nearby several busy roadways in Ann Arbor MI. To complete the entire study, each subject will perform 2 separate study blocks. Minimal total study duration is 2 weeks (washout period = 2 days over weekend) to a maximal period of 6 weeks (wash out period = 5 weeks). During one block, subjects will wear an N-95 respirator facemask (active intervention) during all exposure periods (days 1-5, even during day 1 indoor exposures). Subjects will remove the mask at the end of the study day after all testing is completed. Active versus control intervention ordering will be performed in a randomized single-blind cross-over order. During the other block subjects will wear no facemask (control) during exposure periods. While subjects will necessarily be aware of the intervention type, the study investigators responsible for evaluating the results will be blinded to the intervention type during all data analyses (i.e., single blind trial). Throughout all exposure periods, subjects will wear ambulatory BP monitors (ABPM) and ECG Holter monitors to determine brachial BP/aortic hemodynamics measured every 10 minutes and heart rate variability (HRV) metrics measured continuously and averaged into 10 minute epochs corresponding to same time periods as the BP levels, respectively. Air pollution exposures (PM2.5, black carbon (BC), and ultrafine particle (UFP) count), ambient temperature levels, and noise intensity will be measured continuously at the near-roadway exposure site during all exposure periods (Days 2-5). All environmental exposure metrics will also be averaged into 10 minute epochs during the exposure periods corresponding to the health outcome times. Following completion of exposure periods on day 4 (Thursday), subjects will have endothelial function measured by endoPAT (RHI) immediately post-exposures at the near-roadway site, after lying supine resting 5 minutes on a portable support. Patients will wear facemask throughout RHI testing when in the active intervention block. On the final day 5 of each study block, all subjects will have blood drawn. A sub-group (n=20) of subjects (enrolled on a first-come basis) will have SNS activity measured by MSNA. After blood draws on each study visit day subjects will remove the facemasks and can thereafter carry on with their routine daily activities. However, subjects will be asked to not deviate from their usual lifestyle during each study block. Subjects will be specifically directed to not significantly change their lifestyle (e.g., diet, sleep patterns) and/or any routine activity (e.g., exercise regimen, work, commutes, travel) throughout each study block.

研究类型

介入性

注册 (实际的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Michigan
      • Ann Arbor、Michigan、美国、48103
        • University of Michigan

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • 1. Age 18-65 years old. People older than 65 years are excluded as the impact of PM2.5 on their BP is not known from our prior studies (which included younger individuals) and they have age-related increases in BP and SNS activity which may alter their associations with PM2.5 exposures and thus produce too heterogeneous a population to evaluate the linkages between PM2.5 and health outcomes.
  • 2. Self-reported nonsmoker (100% abstinence for at least 1 year) living in non-smoking households (no one living in the household that smokes indoors) and no known routine exposures to air pollutants by known point sources at home, travel or occupationally (e.g., fumes, dust, secondhand smoke). Smoking and other exposures may alter any effect that ambient PM2.5 has on the health outcomes.
  • 3. Able to understand the informed consent, legally provide informed consent, and able to participate for the entire duration of the study.

Exclusion Criteria:

  • 1. Any facial hair (beard or mustache) that does not allow for proper fitting and air tight seal of the N95 facemask during the study that would compromise the ability of the mask to prevent exposures.
  • 2. Any prior cardiovascular diseases (coronary artery disease (CAD), congestive heart failure (CHF), stroke, peripheral arterial disease (PAD), aneurysms, any revascularization)*
  • 3. Prior diagnosis of hypertension, diabetes, sleep apnea*
  • 4. Prior diagnosis of chronic lung diseases (asthma, chronic obstructive lung disease (COPD))*
  • 5. Prior diagnosis of neurological disorders (Parkinson's disease, autonomic failure, peripheral neuropathy, seizure disorder) or other conditions at discretion of investigators*
  • 6. Prior diagnosis of chronic kidney disease, any type of dialysis*
  • 7. Active or history of any known cancer*
  • 8. History of HIV*
  • 9. Being treated for any infection with antibiotics within past month*
  • 10. Mental health issue(s) including anxiety disorders, mood disorders, schizophrenia, or other conditions at discretion of investigators*
  • 11. Prior diagnosis of any other chronic or acute medical condition(s) at discretion of investigators that may lead to alteration of baseline SNS activity, BP, or insulin sensitivity and thereby potentially impact the association of PM2.5 with study outcomes.
  • 12. Medications for high BP or that alter BP. Any medications for cholesterol (e.g., statins). Any medications that alter blood glucose (e.g., diabetes medication)*.
  • 13. Any medications or over the counter pills that may alter the association between ambient PM2.5 and the health outcomes of BP, SNS activity and insulin sensitivity by discretion of investigators*. No over the counter pills taken on routine basis (>2 times per week as standing dosage) including: anti-oxidants (vitamin C, E), NSAIDS, fish oil supplements, folic acid supplements, multivitamins, or other over the counter pills, herbs, or complimentary therapies under the discretion of the investigators. These pills can be stopped for 3 months on an elective basis and then the individual can enter the study. Other medications for chronic stable conditions that are not listed in exclusion criteria and that are not likely to influence the study results can be taken or continued as long as their doses have been stable for 3 months prior to entering the study. Estrogen or birth control can be used (any type) as long as the dosing has been stable for past 3 months. Medications or over the counter drugs used on an as needed basis (such as Tylenol or aspirin) are fine as long as not routinely taken >2 times per week)* Planned major change in lifestyle including work, activity, exercise, diet, weight during course of study*
  • 14. Screening visit BP ≥140/90 mm Hg (as measured by the automated office BP device- BpTru)
  • 15. Screening visit arm circumference ≥17 inches (makes home BP monitoring inaccurate as the cuff of the commercially-available devices will not fit).
  • 16. Screening visit pregnancy (positive urine pregnancy test in women <50 years of age) and any plan to become pregnant during the study period

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:facemask first then no face mask
wearing of mask each day for the two hours of exposure for the first week of exposure then not wearing the mask each day for the two hours of exposure for the second week of exposure
2 hours' / day exposure to particulate matter face mask worn during exposure.
其他名称:
  • Dettol PROTECT+ Smart Mask
2 hours'/ day exposure to particulate matter with no face mask
实验性的:no face mask followed by wearing face mask
not wearing the mask each day for the two hours of exposure for the first week of exposure then wearing the mask each day for the two hours of exposure for the second week of exposure
2 hours' / day exposure to particulate matter face mask worn during exposure.
其他名称:
  • Dettol PROTECT+ Smart Mask
2 hours'/ day exposure to particulate matter with no face mask

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
blood pressure
大体时间:one week
increased blood pressure as a result of air pollution exposure without the mask.
one week

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Robert Brook, MD、University of Michigan

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2017年4月7日

初级完成 (实际的)

2019年4月30日

研究完成 (实际的)

2019年4月30日

研究注册日期

首次提交

2017年2月10日

首先提交符合 QC 标准的

2017年3月8日

首次发布 (实际的)

2017年3月15日

研究记录更新

最后更新发布 (实际的)

2019年5月2日

上次提交的符合 QC 标准的更新

2019年4月30日

最后验证

2019年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • HUM00122766

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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