HEAT Stress Detection From Personally STandARdized Heat Strain Measurements - The HEATSTAR Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- The within and between subject heat strain marker variability in relation to specific heat stress sources (ambient heat, ambient humidity, exertion, and clothing)
研究概览
简要总结
• This study investigates and compares the within and in-between variances of the body responses to different heat stressors in a controlled lab-setting. The participants will be exposed to different heat sources while a variety of physiological heat strain reactions such as heartrate, sweat rate, and core body temperature are recorded using on- and in-body devices. For the participant monitoring during the study, medical grade devices such as a certified ECG and a swallowable sensor-pill to continuously monitor the core body temperature will be applied. A one-for-all wearable device is additionally applied for physiological validation. Further, sweat will be collected to assess (i) the local sweat rate and (ii) the appearance of different heat stress associated molecular markers in this non-invasively collectable biofluid. As a secondary aim, a model will be developed that will enable to predict the different heat stress sources out of the heat strain measurements.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participant, able to give consent
- •Age 18-40 years
- •Non-athlete (<4h sport/week)
- •BMI<30 (non-obese)
- •German speaking, or fluent in German
排除标准
- •Pregnancy (urine pregnancy test), and breastfeeding
- •Regular medication intake (excluding birth control pill)
- •Intake of drugs and/or daily alcohol consumption
- •Fever or symptoms of an acute infection (cough, shortness of breath, sore throat, taste loss)
- •Active smoking or history of smoking <9 months ago
- •Mobility impairment
- •Traveled (<1 month ago) to a warm/hot temperature zone and stayed for >6 days
- •Any chronic conditions such as: high blood pressure, diabetes mellitus, immuno-deficiencies, sweat disorders such as anhidrosis
- •Color blindness (STROOP test)
- •Weight <40 kg (e-Celsius pill)
- •Diverticulum or obstructions of the gastrointestinal tract (including motility disorders, swallowing disorders) as well as major abdominal surgery (e-Celsius pill)
- •Need of exposure to strong electromagnetic fields during study participation, above all MRI examinations (e-Celsius pill)
结局指标
主要结局
The within and between subject heat strain marker variability in relation to specific heat stress sources (ambient heat, ambient humidity, exertion, and clothing)
时间窗: Max. 7 days
The primary endpoint is the within- and between- subject heat strain marker variability of HR, CBT, WSR, and LSR in relation to various heat stress sources (increased ambient temperature, increased relative humidity, and exertion, all without and with additional clothing.
次要结局
- Accuracy to detect the specific heat stress source (such as ambient heat, relative humidity) from different on- and in-body measurements(Max. 7 days)
- Temperature [°C] and relative humidity [%] of the microenvironment as an additional source of information for patterns to detect heat stressors(Max. 7 days)
- Assessment of short-term heart rate variability in context to each heat stressor.(Max. 7 days)
研究者
Noe Brasier
Principal Investigator
ETH Zurich