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临床试验/NCT06295523
NCT06295523终止不适用

Heat Waves and the Elderly With COPD: Reducing Thermal and Cardiovascular Consequences

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
1
主要终点
Core body temperature

研究概览

简要总结

The purpose of this study is to investigate thermoregulatory responses in older individuals with COPD.

详细描述

Heat waves are the leading cause of death among natural disasters in the United States.

Elderly individuals are disproportionately more likely to become ill or die during heat waves. While the elderly have a reduced ability to regulate their body temperature,8-10 hospitalizations and deaths in this population during heat waves are primarily due to cardiovascular and/or respiratory complications, not solely hyperthermia. While previous research has primarily focused on the thermal and cardiovascular consequences of healthy aging, very little research has focused on the physiological responses to heat exposure in older individuals with chronic disease, such as chronic obstructive pulmonary disease (COPD). Notably, epidemiological data suggests that pulmonary complications are a leading cause of heat wave-related hospitalizations in older adults with a diagnosis of COPD, yet nothing is known regarding the physiological mechanisms by which those with COPD are most susceptible to heat waves. To fill this important gap, the investigators will identify the physiological responses that occur in this population, relative to healthy age-matched individuals, during two unique heat wave simulations.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •65 years old or older
  • •Diagnosis of COPD

排除标准

  • •Known heart disease
  • •Other chronic medical conditions requiring regular medical therapy including cancer, diabetes, uncontrolled hypertension, and uncontrolled hypercholesterolemia etc
  • •Abnormality detected on routine screening suggestive of provokable ischemia or previously undetected cardiac disease or resting left bundle branch block on screening electrocardiogram
  • •Current smokers
  • •Participant with a body mass index ≥31 kg/m2

研究组 & 干预措施

Experimental: Very hot and dry

Experimental

Subjects will be exposed to 3 hours in a climate chamber set to approximately 47 deg C and 15% relative humidity, which reflects a very hot and dry heat wave condition similar to the 2018 Los Angeles heat wave. Two visits will be required to complete this arm, with one visit including water spray for cooling.

干预措施: Control (Other)

Experimental: Hot and humid

Experimental

Subjects will be exposed to 3 hours in a climate chamber set to approximately 41 deg C and 40% relative humidity, which reflects hot and humid heat wave similar to the 1995 Chicago heat wave. Two visits will be required to complete this arm, with one visit including water spray for cooling.

干预措施: Control (Other)

Experimental: Hot and humid

Experimental

Subjects will be exposed to 3 hours in a climate chamber set to approximately 41 deg C and 40% relative humidity, which reflects hot and humid heat wave similar to the 1995 Chicago heat wave. Two visits will be required to complete this arm, with one visit including water spray for cooling.

干预措施: Water Spray (Other)

Experimental: Very hot and dry

Experimental

Subjects will be exposed to 3 hours in a climate chamber set to approximately 47 deg C and 15% relative humidity, which reflects a very hot and dry heat wave condition similar to the 2018 Los Angeles heat wave. Two visits will be required to complete this arm, with one visit including water spray for cooling.

干预措施: Water Spray (Other)

结局指标

主要结局

Core body temperature

时间窗: Prior to and throughout each simulated heat wave exposure, an average of 480 minutes

Core body temperature will be measure from gastrointestinal temperature via an ingestible telemetric pill

Forced vital capacity (FVC)

时间窗: Prior to, during, and after each simulated heat wave exposure, approximately 10 min each

FVC will be assessed via spirometry

Forced expiratory volume (FEV1)

时间窗: Prior to, during, and after each simulated heat wave exposure, approximately 10 min each

FEV1 will be assessed via spirometry

FEV1/FVC ratio

时间窗: Prior to, during, and after each simulated heat wave exposure, approximately 10 min each

The ratio of forced expiratory volume and forced vital capacity will be assessed via spirometry

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Craig Crandall

Professor of Internal Medicine

University of Texas Southwestern Medical Center

研究点 (1)

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