Non-invasive Prediction of Thermal Strain in Healthy Male Adults

Heat Stress Clinical Trial

— HUMONHEAT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04650776
• Other study ID #: 5213.00095
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: November 2020
• Source: Empa, Swiss Federal Laboratories for Materials Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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).

Related Conditions & MeSH terms

• Heat Stress
• Heat Stress Disorders

Intervention

Other:
• Heat strain
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.

Locations

Country	Name	City	State
Switzerland	Empa	St.Gallen	SG

Sponsors (1)

Lead Sponsor	Collaborator
Simon Annaheim

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core body temperature	Rectal core body temperature (unit of measure is degree celsius °C)	90 minutes
Primary	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)	90 minutes
Primary	ECG-based heat strain index	ECG-based index of heat strain derived from heart rate variability	90 minutes

External Links

•   Published manuscript