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Completed

NCT Number: NCT04650776

Non-invasive Prediction of Thermal Strain in Healthy Male Adults

This is primarily an experimental study investigating methods of temperature measurement / heat strain detection. In the calibration study, there are different skin temperature sensor types, and in the prediction study there are different methods for determining heat strain, including conventional methods (rectal, gastro-intestinal), the development of a prediction model, and an index based on heart rate variability.

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Key information

Conditions

Heat Stress Heat Stress Disorders Wounds and Injuries

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Empa

Sankt Gallen, Canton of St. Gallen, 9014, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Apparently healthy males
  • aged 18-45 y
  • regularly participate in sport, exercise, or equivalent physical activity on a weekly basis.

Exclusion criteria

  • Known injuries or illnesses that may affect safe participation. These include injuries or illnesses involving (but not limited to):
  • cardiovascular, renal, or gastrointestinal tract
  • heat or exercise intolerance
  • acute infections,
  • immunological diseases (including asthma)
  • psychiatric disorders.
  • Participants must not be currently or previously on cardiovascular-related medication and must not be taking psychotropic medication (last 60 days).

Treatment and study plan

Heat strain

Other

The experimental procedure comprised 15 min baseline seated rest (23.2 ± 0.3°C, 24.5 ± 1.6% relative humidity), followed by 15 min seated rest and cycling in a climatic chamber (35.4 ± 0.2◦C, 56.5 ± 3.9% relative humidity; to +1.5◦C or maximally 38.5°C rectal temperature, duration 20-60 min), with a final 30 min seated rest outside the chamber.

Primary outcomes

  1. Core body temperature

    Time frame: 90 minutes

    Rectal core body temperature (unit of measure is degree celsius °C)

  2. Predicted core body temperature

    Time frame: 90 minutes

    Estimated core body temperature (°C) from selected non-invasive measurements: applying a multiple linear regression model several predictive parameters, including skin temperature at different body sites, heat flux at different body sites, and heart rate will be combined to achieve one reported temperature value (°C)

  3. ECG-based heat strain index

    Time frame: 90 minutes

    ECG-based index of heat strain derived from heart rate variability

Sponsors and collaborators

Lead sponsor

Simon Annaheim

Other

Registry information

Official study title

Single-centre Experimental Evaluation of Methods for Reliable Non-invasive Prediction of Thermal Strain in Healthy Male Adults

Acronym: HUMONHEAT

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 3, 2020
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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