Heat StressHUMONHEATNCT04650776
Non-invasive Prediction of Thermal Strain in Healthy Male Adults
A study testing Heat strain in people with Heat Stress, run by Simon Annaheim at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Heat Stress
- What is being tested?
- Heat strain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Sep 2017to 30 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apparently healthy males
- aged 18-45 y
- regularly participate in sport, exercise, or equivalent physical activity on a weekly basis.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-centre Experimental Evaluation of Methods for Reliable 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.
- Conditions
- Heat Stress
- Being tested
- Heat strain
- Medical subject headings
- Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heat strainOther
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.
| Study group | Role | What they receive |
|---|---|---|
| High heat strain | Experimental | participants exercised at 75% of their heart rate maximum (HR max) and wore light athletic clothing (t-shirt and shorts) Receives: Other: Heat strain |
| Low heat strain | Experimental | participants exercised at 50% HR max, wearing protective firefighter clothing (jacket and trousers) Receives: Other: Heat strain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core body temperature
Rectal core body temperature (unit of measure is degree celsius °C)
Measured: 90 minutes
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)
Measured: 90 minutes
ECG-based heat strain index
ECG-based index of heat strain derived from heart rate variability
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start1 Sep 2017
- Primary completion30 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heat StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Simon Annaheim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Simon Annaheim, Empa, Swiss Federal Laboratories for Materials Science and Technology
- Investigators
- Simon Annaheim, Dr., Principal investigator, Empa, Swiss Federal Laboratories for Materials Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650776
- Sponsor's protocol ID
- 5213.00095
- Acronym
- HUMONHEAT
- Status last verified
- Nov 2020
- First submitted
- 19 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is available upon request from qualified researchers.
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-centre Experimental Evaluation of Methods for Reliable Non-invasive Prediction of Thermal Strain in Healthy Male Adults
- ClinicalTrials.gov ID
- NCT04650776
- Acronym / sponsor ID
- HUMONHEAT / 5213.00095
- Conditions
- Heat Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Simon AnnaheimUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High heat strain | Experimental | Other: Heat strainparticipants exercised at 75% of their heart rate maximum (HR max) and wore light athletic clothing (t-shirt and shorts) |
| Low heat strain | Experimental | Other: Heat strainparticipants exercised at 50% HR max, wearing protective firefighter clothing (jacket and trousers) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Apparently healthy males
- aged 18-45 y
- regularly participate in sport, exercise, or equivalent physical activity on a weekly basis.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heat strainThe 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. | Other | High heat strain, Low heat strain |
Primary outcome
Core body temperature
Time frame: 90 minutes
Rectal core body temperature (unit of measure is degree celsius °C)
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)
ECG-based heat strain index
Time frame: 90 minutes
ECG-based index of heat strain derived from heart rate variability
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Published manuscriptLink provided by the sponsor.
- Individual participant dataSharing planned: No. Data is available upon request from qualified researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Simon Annaheim, Dr. principal investigator
Empa, Swiss Federal Laboratories for Materials Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heat strain in people with Heat Stress, run by Simon Annaheim at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core body temperature (time frame: 90 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2020.