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CompletedNCT05622188HEATSTARUpdated Feb 13, 2023

The Detection of Heat Stress by Assessing Individual Body Responses to Heat (Heat Strain) in Young and Healthy Non-athlete Participants

An observational study in Heat Stress, sponsored by ETH Zurich. Completed at 1 site in Switzerland. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-13.

Sponsored by ETH Zurich · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
23
Ages
18 Years to 40 Years
Sex
All
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Study 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.
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Conditions studied

  • Heat Stress

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Keywords

  • Heat Strain
  • Wearable
  • Sweat Analysis
03

In context

Heat Stress Disorders

111 studies on the registry are indexed under Heat Stress Disorders; 45 are open to participants now.

This study's enrollment of 23 is below the median of 55 across 13 observational studies indexed under Heat Stress Disorders.

Browse Heat Stress Disorders studies →

Lead sponsor

ETH Zurich is the lead sponsor of 19 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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)
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
23 participants (actual)
Patient registry
No

Groups and cohorts

  • Healthy participants

    Age of the participants is between 18-40 years, females and males equally distributed

    Other: Elevated ambient heat · Other: Elevated relative humidity · Other: Exertion

Interventions

  • OtherElevated ambient heat

    Temporary exposure to increased ambient temperature +10°C (the effect of the intervention is fully and spontaneously reversible)

  • OtherElevated relative humidity

    Temporary exposure to increased ambient relative humidity +40% (max. 90%) (the effect of the intervention is fully and spontaneously reversible)

  • OtherExertion

    Temporary exertion on an ergometer (1W/kg body weight) (the effect of the intervention is fully and spontaneously reversible)

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What researchers measure

Primary outcomes

  1. The within and between subject heat strain marker variability in relation to specific heat stress sources (ambient heat, ambient humidity, exertion, and clothing)

    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.

    Time frame: Max. 7 days

Secondary outcomes

  1. Accuracy to detect the specific heat stress source (such as ambient heat, relative humidity) from different on- and in-body measurements

    The models for the primary endpoints will be extended to explore the relationships between heat strain parameters, heat stress sources, as well as personal characteristics. Additionally, prediction of heat stress source will be explored.

    Time frame: Max. 7 days

  2. Assessment of short-term heart rate variability in context to each heat stressor.

    Short-term HRV with a repeating time frame of 5min. Root mean square of successive RR interval (RMSSD; in \[ms\]) and the Standard-deviation of RR intervals (SDRR; in \[ms\]) will be computed with respect to each heat stress source.

    Time frame: Max. 7 days

  3. Temperature [°C] and relative humidity [%] of the microenvironment as an additional source of information for patterns to detect heat stressors

    Features of temperature \[°C\] and relative humidity \[%\] of the microenvironment as additional model predictors.

    Time frame: Max. 7 days

Other outcomes

  1. The relation between cognitive assessment and skin temperature

    Correlation between subjective heat comfort (Visual Analog Scale, where +1 is comfortable and +4 is very uncomfortable) and baseline differential stress inventory (causes of stress, symptoms of stress, coping, stress stabilization) in relation to skin temperature \[°C\]

    Time frame: Max. 7 days

  2. The relation between STROOP assessment and different heat stressors

    Correlation between changes in the STROOP assessment outcome (number of errors and time of decision \[ms\], between beginning and end of heat stress exposure) in context to the various heat stress sources, skin temperature, and thermal comfort.

    Time frame: Max. 7 days

  3. Novel Sweat Biomarkers for heat stress detection

    Descriptive statistics for novel non-invasive biomarkers from sweat analysis with respect to heat stress source, including between- and within-subject variability

    Time frame: Max. 7 days

  4. Recording heat strain parameters with an all-for-one device

    The 'reliability' (missing data per minute (\[%\]) and the 'accuracy' (HR \[bpm\] with 95% confidence intervals), CBT (in \[°C\] with 95% confidence intervals), and local sweat rate measurements (in \[g/h\] with 95% confidence intervals) of the wearable device in recording vital parameters.

    Time frame: Max. 7 days

07

Study locations

1 site
  • ETH Zurich
    Zurich, Andere (Nicht USA-Länder) 8093, Switzerland
08

References and documents

Publications

  • Watts N, Amann M, Ayeb-Karlsson S, Belesova K, Bouley T, Boykoff M, Byass P, Cai W, Campbell-Lendrum D, Chambers J, Cox PM, Daly M, Dasandi N, Davies M, Depledge M, Depoux A, Dominguez-Salas P, Drummond P, Ekins P, Flahault A, Frumkin H, Georgeson L, Ghanei M, Grace D, Graham H, Grojsman R, Haines A, Hamilton I, Hartinger S, Johnson A, Kelman I, Kiesewetter G, Kniveton D, Liang L, Lott M, Lowe R, Mace G, Odhiambo Sewe M, Maslin M, Mikhaylov S, Milner J, Latifi AM, Moradi-Lakeh M, Morrissey K, Murray K, Neville T, Nilsson M, Oreszczyn T, Owfi F, Pencheon D, Pye S, Rabbaniha M, Robinson E, Rocklov J, Schutte S, Shumake-Guillemot J, Steinbach R, Tabatabaei M, Wheeler N, Wilkinson P, Gong P, Montgomery H, Costello A. The Lancet Countdown on health and climate change: from 25 years of inaction to a global transformation for public health. Lancet. 2018 Feb 10;391(10120):581-630. doi: 10.1016/S0140-6736(17)32464-9. Epub 2017 Oct 30. No abstract available. Erratum In: Lancet. 2018 Feb 10;391(10120):540. doi: 10.1016/S0140-6736(17)33046-5. Lancet. 2020 Jun 6;395(10239):1762. doi: 10.1016/S0140-6736(20)31197-1. PubMed 29096948 ↗
  • Varghese BM, Hansen A, Bi P, Pisaniello D. Are workers at risk of occupational injuries due to heat exposure? A comprehensive literature review. Safety Science. 2018;110:380-92.
  • Davey SL, Downie V, Griggs K, Havenith G. The physiological strain index does not reliably identify individuals at risk of reaching a thermal tolerance limit. Eur J Appl Physiol. 2021 Jun;121(6):1701-1713. doi: 10.1007/s00421-021-04642-3. Epub 2021 Mar 7. PubMed 33677693 ↗
  • Nunes MJ, Cordas CM, Moura JJG, Noronha JP, Branco LC. Screening of Potential Stress Biomarkers in Sweat Associated with Sports Training. Sports Med Open. 2021 Jan 22;7(1):8. doi: 10.1186/s40798-020-00294-3. PubMed 33481103 ↗
  • Flores M, Glusman G, Brogaard K, Price ND, Hood L. P4 medicine: how systems medicine will transform the healthcare sector and society. Per Med. 2013;10(6):565-576. doi: 10.2217/pme.13.57. PubMed 25342952 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05622188
Lead sponsor
ETH Zurich
Collaborators
Swiss Federal Office of Sports (BASPO), University of Zurich, Center for Chronobiology, Psychiatric University Clinics, Basel, epyMetrics, Innosuisse - Swiss Innovation Agency, Swiss Federal Railways
Responsible party
Noe Brasier (Principal Investigator, ETH Zurich) — Principal investigator
First posted
Nov 18, 2022
Start date
Nov 2, 2022
Primary completion
Jan 31, 2023
Completion
Feb 10, 2023
Last update
Feb 13, 2023

Study contacts

Noé Brasier, MD
principal investigator · ETH Zurich

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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