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

NCT ID: NCT05622188

Last Updated: 2023-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-02

Study Completion Date

2023-02-10

Brief Summary

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• 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.

Detailed Description

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Conditions

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Heat Stress

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy participants

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

Elevated ambient heat

Intervention Type OTHER

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

Elevated relative humidity

Intervention Type OTHER

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

Exertion

Intervention Type OTHER

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

Interventions

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Elevated ambient heat

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

Intervention Type OTHER

Elevated relative humidity

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

Intervention Type OTHER

Exertion

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

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Swiss Federal Office of Sports (BASPO)

UNKNOWN

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role collaborator

Center for Chronobiology, Psychiatric University Clinics, Basel

UNKNOWN

Sponsor Role collaborator

epyMetrics

UNKNOWN

Sponsor Role collaborator

Innosuisse - Swiss Innovation Agency

OTHER

Sponsor Role collaborator

Swiss Federal Railways

UNKNOWN

Sponsor Role collaborator

ETH Zurich

OTHER

Sponsor Role lead

Responsible Party

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Noe Brasier

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noé Brasier, MD

Role: PRINCIPAL_INVESTIGATOR

ETH Zurich

Locations

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ETH Zurich

Zurich, Andere (Nicht USA-Länder), Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 29096948 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 33677693 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33481103 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25342952 (View on PubMed)

Other Identifiers

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EKNZ ID: 2022 - 01325

Identifier Type: -

Identifier Source: org_study_id

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