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Non-invasive Prediction of Thermal Strain in Healthy Male Adults (HUMONHEAT)

Primary Purpose

Heat Stress

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Heat strain
Sponsored by
Simon Annaheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Heat Stress

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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).

Sites / Locations

  • Empa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High heat strain

Low heat strain

Arm Description

participants exercised at 75% of their heart rate maximum (HR max) and wore light athletic clothing (t-shirt and shorts)

participants exercised at 50% HR max, wearing protective firefighter clothing (jacket and trousers)

Outcomes

Primary Outcome Measures

Core body temperature
Rectal core body temperature (unit of measure is degree celsius °C)
Predicted core body temperature
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)
ECG-based heat strain index
ECG-based index of heat strain derived from heart rate variability

Secondary Outcome Measures

Full Information

First Posted
November 19, 2020
Last Updated
November 25, 2020
Sponsor
Simon Annaheim
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1. Study Identification

Unique Protocol Identification Number
NCT04650776
Brief Title
Non-invasive Prediction of Thermal Strain in Healthy Male Adults
Acronym
HUMONHEAT
Official Title
Single-centre Experimental Evaluation of Methods for Reliable Non-invasive Prediction of Thermal Strain in Healthy Male Adults
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
April 30, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Simon Annaheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heat Stress

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High heat strain
Arm Type
Experimental
Arm Description
participants exercised at 75% of their heart rate maximum (HR max) and wore light athletic clothing (t-shirt and shorts)
Arm Title
Low heat strain
Arm Type
Experimental
Arm Description
participants exercised at 50% HR max, wearing protective firefighter clothing (jacket and trousers)
Intervention Type
Other
Intervention Name(s)
Heat strain
Intervention Description
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 Outcome Measure Information:
Title
Core body temperature
Description
Rectal core body temperature (unit of measure is degree celsius °C)
Time Frame
90 minutes
Title
Predicted core body temperature
Description
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)
Time Frame
90 minutes
Title
ECG-based heat strain index
Description
ECG-based index of heat strain derived from heart rate variability
Time Frame
90 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Annaheim, Dr.
Organizational Affiliation
Empa, Swiss Federal Laboratories for Materials Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Empa
City
St.Gallen
State/Province
SG
ZIP/Postal Code
9014
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data is available upon request from qualified researchers.
Links:
URL
https://www.frontiersin.org/articles/10.3389/fphys.2018.01780/full
Description
Published manuscript

Learn more about this trial

Non-invasive Prediction of Thermal Strain in Healthy Male Adults

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