Clinical trial NCT05622188: The Detection of Heat Stress by Assessing Individual Body Responses to Heat (Heat Strain) in Young and Healthy Non-athlete Participants
Official title: HEAT Stress Detection From Personally STandARdized Heat Strain Measurements - The HEATSTAR Pilot Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heat Stress
Keywords: Heat Strain
Wearable
Sweat Analysis
Lead sponsor: ETH Zurich
Sponsor class: OTHER
Collaborators: name: Swiss Federal Office of Sports (BASPO)
name: University of Zurich
name: Center for Chronobiology, Psychiatric University Clinics, Basel
name: epyMetrics
name: Innosuisse - Swiss Innovation Agency
name: Swiss Federal Railways
First posted: 2022-11-18
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited through Swiss Universities and Swiss Universities of Applied Science. The institutions host a broad range of students that are likely to match the inclusion criteria.

Brief summary: • 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: The within and between subject heat strain marker variability in relation to specific heat stress sources (ambient heat, ambient humidity, exertion, and clothing)
timeFrame: Max. 7 days
Secondary outcomes:
measure: Accuracy to detect the specific heat stress source (such as ambient heat, relative humidity) from different on- and in-body measurements
timeFrame: Max. 7 days
measure: Assessment of short-term heart rate variability in context to each heat stressor.
timeFrame: Max. 7 days
measure: Temperature [°C] and relative humidity [%] of the microenvironment as an additional source of information for patterns to detect heat stressors
timeFrame: Max. 7 days
Other outcomes:
measure: The relation between cognitive assessment and skin temperature
timeFrame: Max. 7 days
measure: The relation between STROOP assessment and different heat stressors
timeFrame: Max. 7 days
measure: Novel Sweat Biomarkers for heat stress detection
timeFrame: Max. 7 days
measure: Recording heat strain parameters with an all-for-one device
timeFrame: Max. 7 days
Locations:
city: Zurich
country: Switzerland
facility: ETH Zurich
state: Andere (Nicht USA-Länder)
Study officials:
affiliation: ETH Zurich
name: Noé Brasier, MD
role: PRINCIPAL_INVESTIGATOR
References:
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