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
About this trial
This is an interventional screening trial for Heat Stress
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).
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
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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