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Heat StressHEATSTARNCT05622188

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

An observational study of Heat Stress, run by ETH Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Heat Stress
What is being tested?
Elevated ambient heat, Elevated relative humidity and Exertion
How many people
23 participants
Where
1 siteSwitzerland
Study dates
2 Nov 2022to 10 Feb 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • ETH Zurich

    Zurich, Andere (Nicht USA-Länder), 8093

Other trials in Switzerland

About this study

Official title: HEAT Stress Detection From Personally STandARdized Heat Strain Measurements - The HEATSTAR Pilot Trial

  • 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.
Conditions
Heat Stress
Being tested
Elevated ambient heat, Elevated relative humidity, Exertion
Keywords
Heat Strain, Wearable, Sweat Analysis
Medical subject headings
Heat Stress Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elevated ambient heatOther

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

  • Elevated relative humidityOther

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

  • ExertionOther

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

Study groups in NCT05622188
Study groupRoleWhat they receive
Healthy participantsAge of the participants is between 18-40 years, females and males equally distributed
Receives: Other: Elevated ambient heat; Other: Elevated relative humidity; Other: Exertion

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Max. 7 days

Secondary outcomes (3)

  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.

    Measured: 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.

    Measured: 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.

    Measured: Max. 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2022
  2. Study start2 Nov 2022
  3. Primary completion31 Jan 2023
  4. Study completion10 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Cross-sectional
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05622188
Sponsor's protocol ID
EKNZ ID: 2022 - 01325
Acronym
HEATSTAR
Status last verified
Feb 2023
First submitted
11 Nov 2022
Last updated
13 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    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

Questions about this trial

What is this clinical trial studying?

An observational study of Heat Stress, run by ETH Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The within and between subject heat strain marker variability in relation to specific heat stress sources (ambient heat, ambient humidity, exertion, and clothing) (time frame: Max. 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05622188, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2023.

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