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

Heat Stress Clinical Trial

— HEATSTAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05622188
• Other study ID #: EKNZ ID: 2022 - 01325
• Status: Completed
• Start date: November 2, 2022
• Est. completion date: February 10, 2023

Study information

• Verified date: February 2023
• Source: ETH Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: February 10, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Heat Stress
• Heat Stress Disorders

Intervention

Other:
• Elevated ambient heat
Temporary exposure to increased ambient temperature +10°C (the effect of the intervention is fully and spontaneously reversible)
• Elevated relative humidity
Temporary exposure to increased ambient relative humidity +40% (max. 90%) (the effect of the intervention is fully and spontaneously reversible)
• Exertion
Temporary exertion on an ergometer (1W/kg body weight) (the effect of the intervention is fully and spontaneously reversible)

Locations

Country	Name	City	State
Switzerland	ETH Zurich	Zurich	Andere (Nicht USA-Länder)

Sponsors (7)

Lead Sponsor	Collaborator
ETH Zurich	Center for Chronobiology, Psychiatric University Clinics, Basel, epyMetrics, Functional Genomics Center, ETH Zurich/University of Zurich, Innosuisse - Swiss Innovation Agency, Swiss Federal Office of Sports (BASPO), Swiss Federal Railways

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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.

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. 2017 Nov 23;: Lancet. 2020 Jun 6;395(10239):1762. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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]	Max. 7 days
Other	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.	Max. 7 days
Other	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	Max. 7 days
Other	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.	Max. 7 days
Primary	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	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.	Max. 7 days
Secondary	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.	Max. 7 days
Secondary	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.	Max. 7 days