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

NCT05622188 | Completed

• 1 other identifier: EKNZ ID: 2022 - 01325
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Heat Stress

Keywords

Heat Strain; Wearable; Sweat Analysis

Outcome Measures

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.

  Max. 7 days

Secondary Outcomes (3)

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

  Max. 7 days

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

  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

Other Outcomes (4)

• The relation between cognitive assessment and skin temperature

  Max. 7 days

• The relation between STROOP assessment and different heat stressors

  Max. 7 days

• Novel Sweat Biomarkers for heat stress detection

  Max. 7 days

Study Arms (1)

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

Elevated ambient heat OTHER

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

Healthy participants

Elevated relative humidity OTHER

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

Healthy participants

Exertion OTHER

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

Healthy participants

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• ETH Zurich: lead
• Swiss Federal Office of Sports (BASPO): collaborator
• University of Zurich: collaborator
• Center for Chronobiology, Psychiatric University Clinics, Basel: collaborator
• epyMetrics: collaborator
• Innosuisse - Swiss Innovation Agency: collaborator
• Swiss Federal Railways: collaborator

Study Sites (1)

ETH Zurich

Zurich, Andere (Nicht USA-Länder), 8093, Switzerland

Location

Related Publications (5)

• 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.

  PMID: 29096948 BACKGROUND

• 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.

  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.

  PMID: 33677693 BACKGROUND

• 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.

  PMID: 33481103 BACKGROUND

• 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.

  PMID: 25342952 BACKGROUND

MeSH Terms

Conditions

Heat Stress Disorders

Interventions

Physical Exertion

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Noé Brasier, MD

  ETH Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: November 18, 2022
• Study Start: November 2, 2022
• Primary Completion: January 31, 2023
• Study Completion: February 10, 2023
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)