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临床试验 NCT07501923 针对Metabolism Changes，Psychology Functional Behavior，心血管系统，呼吸系统目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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The Effects of Daytime, Nighttime, and Combined Heat Exposure on Human Health 35
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临床试验NCT07501923是一项针对Metabolism Changes，Psychology Functional Behavior，心血管系统，呼吸系统的干预性研究试验，目前试验状态为招募中。试验始于2025年6月1日，计划招募35名患者。该研究由Jian Cheng主导，预计于2026年12月31日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月30日。
简要概括
Assess the acute effects of high-temperature exposure (including both daytime and nighttime conditions) on multiple physiological and psychological indicators, including cardiovascular, respiratory, neuropsychiatric, and metabolic functions, along with their potential mechanisms.
详细描述
This study will be conducted in Hefei, China, as a randomized controlled crossover human exposure trial involving approximately 50 healthy young adults. The primary objective is to systematically evaluate the acute effects of heat exposure-during both daytime and nighttime-on multiple physiological and psychological domains, including cardiovascular, respiratory, neurocognitive, and metabolic functions, and to explor...显示更多
官方标题
Randomized Controlled Crossover Trial on the Effects of Daytime, Nighttime, and Combined Heat Exposure on Human Health
疾病
Metabolism ChangesPsychology Functional Behavior心血管系统呼吸系统其他研究标识符
- 81250681
NCT编号
实际开始日期
2025-06-01
最近更新发布
2026-03-30
预计完成日期
2026-12-31
计划入组人数
35
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
招募中
主要目的
治疗方法
分配方式
随机
干预模型
交叉设计
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
其他Intervention / Treatment Daytime or Nighttime High-Temperature Group | Daytime or Nighttime High-Temperature Exposure Daytime Exposure Phase:
The exposure group will be exposed to high temperature (32#) in a chamber for about 8 hours, resting during the whole periods
Nighttime Exposure Phase:
The exposure group will be exposed to high temperature (30#) in a chamber for about 8 hours, resting during the whole periods
Day-Night Combined Exposure Phase:
The exposure group will be exposed continuously to high temperatures during th...显示更多 |
其他Control Daytime or Nighttime Neutral -Temperature Group | Daytime and nighttime neutral temperature exposure Daytime Exposure Phase:
The control group will be exposed to neutraltemperature (26#) in a chamber for about 8 hours, resting during the whole periods
Nighttime Exposure Phase:
The control group will be exposed to neutral temperature (26#) in a chamber for about 8 hours, resting during the whole periods
Day-Night Combined Exposure Phase:
The control group will be exposed continuously to neutraltemperatures durin...显示更多 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Heart Rate Variability | Smart Band will be conducted during each exposure session. Time-domain and frequency-domain HRV indices (e.g., SDNN, RMSSD, LF, HF) will be derived to assess autonomic nervous system regulation. | Volunteers will be asked to wear smart band for 24 hours from 6:00 A.M. at the day of intervention to 6:00 A.M. at the next day. |
Systolic and Diastolic Blood Pressure | Blood pressure will be measured using an automated sphygmomanometer under standardized resting conditions. Both systolic and diastolic values will be recorded. | Blood pressure will be examined before exposure and immediately (within 10 mins) after the exposure session |
Forced Expiratory Volume in 1 Second | Pulmonary function will be assessed using spirometry according to standardized protocols. FEV1 will be recorded as a measure of airway function. | Lung function will be examined before exposure and half an hour after the exposure session |
Forced Vital Capacity | Forced vital capacity will be measured via spirometry to evaluate lung volume and ventilatory function. | Lung function will be examined before exposure and half an hour after the exposure session |
Interleukin-6 | Venous blood samples will be collected and serum IL-6 concentrations will be quantified using enzyme-linked immunosorbent assay (ELISA) to assess systemic inflammatory response. | Blood will be collected 1 hour before and after the exposure session |
C-reactive Protein | Serum CRP levels will be measured using high-sensitivity assays as a marker of systemic inflammation. | Blood will be collected 1 hour before and after the exposure session |
F2-Isoprostanes | Plasma or urinary F2-isoprostanes will be quantified using validated assays as a stable biomarker of lipid peroxidation and oxidative stress. | Blood will be collected 1 hour before and after the exposure session |
Superoxide Dismutase | Serum SOD activity will be measured to evaluate antioxidant defense capacity. | Blood will be collected 1 hour before and after the exposure session |
Serum Creatinine | Serum creatinine will be measured using standard biochemical methods to assess renal function. | Blood will be collected 1 hour before and after the exposure session |
Urinary Neutrophil Gelatinase-Associated Lipocalin | Urinary NGAL levels will be quantified using ELISA as an early biomarker of acute kidney injury. | Urine will be collected 1 hour before and after the exposure session |
Profile of Mood States | Psychological status will be assessed using the validated POMS questionnaire to evaluate mood disturbances. | Scale assessments will be conducted within one hour before and after exposure. |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Heart Rate | Heart rate will be continuously recorded during exposure using wearable devices. | Volunteers will be asked to wear smart band for 24 hours from 6:00 A.M. at the day of intervention to 6:00 A.M. at the next day. |
Peak Expiratory Flow | PEF will be measured using a portable peak flow meter to assess expiratory function. | Lung function will be examined before exposure and half an hour after the exposure session |
Tumor Necrosis Factor-alpha | Serum TNF-α levels will be measured using ELISA. | Blood will be collected 1 hour before and after the exposure session |
Monocyte Chemoattractant Protein-1 | Serum MCP-1 concentrations will be quantified to assess inflammatory activation. | Blood will be collected 1 hour before and after the exposure session |
Glutathione | Reduced glutathione levels will be measured to assess antioxidant capacity. | Blood will be collected 1 hour before and after the exposure session |
Blood Urea Nitrogen | Blood Urea Nitrogen will be measured using standard biochemical assays. | Blood will be collected 1 hour before and after the exposure session |
Perceived Stress Scale | Perceived stress will be assessed using the validated Perceived Stress Scale questionnaire. | Scale assessments will be conducted within one hour before and after exposure. |
参与助手
资格标准
适龄参与研究
成人
最低年龄要求
18 Years
适龄性别
全部
接受健康志愿者
是
- Age 18-30;
- In good health, with no history of cardiovascular disease, respiratory disease, diabetes, endocrine disorders, neurological or psychiatric conditions;
- No smoking or alcohol addiction, no history of substance abuse;
- No prior history of particular sensitivity to high-temperature environments.
- Individuals who have experienced fever, colds, infectious diseases, or significant physical trauma within two weeks prior to the high-temperature test;
- Individuals currently using medications that may affect psychological, cognitive, cardiovascular, or respiratory functions;
- Pregnant women and lactating females;
- Participants shall not be scheduled to participate during menstruation;
- Individuals with a history of fainting or severe discomfort caused by high temperatures.
Jian Cheng研究责任方
Jian Cheng, 申办者-研究者, Professor, Anhui Medical University
研究中心联系人
联系人: Jian Jian Cheng, +86 183 5603 7837, [email protected]
1 位于 1 个国家/地区的研究中心
Anhui
Anhui Medical University, Hefei, Anhui, 230032, China
Jian Jian Cheng, 联系人, +86 183 5603 7837, [email protected]
招募中