The Detection of Heat Stress by Assessing Individual Body Responses to Heat (Heat Strain) in Young and Healthy Non-athlete Participants (HEATSTAR)

February 10, 2023 updated by: Noe Brasier, ETH Zurich

HEAT Stress Detection From Personally STandARdized Heat Strain Measurements - The HEATSTAR Pilot Trial

• This study investigates and compares the within and in-between variances of the body responses to different heat stressors in a controlled lab-setting. The participants will be exposed to different heat sources while a variety of physiological heat strain reactions such as heartrate, sweat rate, and core body temperature are recorded using on- and in-body devices. For the participant monitoring during the study, medical grade devices such as a certified ECG and a swallowable sensor-pill to continuously monitor the core body temperature will be applied. A one-for-all wearable device is additionally applied for physiological validation. Further, sweat will be collected to assess (i) the local sweat rate and (ii) the appearance of different heat stress associated molecular markers in this non-invasively collectable biofluid. As a secondary aim, a model will be developed that will enable to predict the different heat stress sources out of the heat strain measurements.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Switzerland
    • Andere (Nicht USA-Länder)
      • Zurich, Andere (Nicht USA-Länder), Switzerland, 8093
        • ETH Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be recruited through Swiss Universities and Swiss Universities of Applied Science. The institutions host a broad range of students that are likely to match the inclusion criteria.

Description

Inclusion Criteria:

  • Healthy participant, able to give consent
  • Age 18-40 years
  • Non-athlete (<4h sport/week)
  • BMI<30 (non-obese)
  • German speaking, or fluent in German

Exclusion Criteria:

  • Pregnancy (urine pregnancy test), and breastfeeding
  • Regular medication intake (excluding birth control pill)
  • Intake of drugs and/or daily alcohol consumption
  • Fever or symptoms of an acute infection (cough, shortness of breath, sore throat, taste loss)
  • Active smoking or history of smoking <9 months ago
  • Mobility impairment
  • Traveled (<1 month ago) to a warm/hot temperature zone and stayed for >6 days
  • Any chronic conditions such as: high blood pressure, diabetes mellitus, immuno-deficiencies, sweat disorders such as anhidrosis
  • Color blindness (STROOP test)
  • Weight <40 kg (e-Celsius pill)
  • Diverticulum or obstructions of the gastrointestinal tract (including motility disorders, swallowing disorders) as well as major abdominal surgery (e-Celsius pill)
  • Need of exposure to strong electromagnetic fields during study participation, above all MRI examinations (e-Celsius pill)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy participants
Age of the participants is between 18-40 years, females and males equally distributed
Other: Elevated ambient heat
Temporary exposure to increased ambient temperature +10°C (the effect of the intervention is fully and spontaneously reversible)
Other: Elevated relative humidity
Temporary exposure to increased ambient relative humidity +40% (max. 90%) (the effect of the intervention is fully and spontaneously reversible)
Other: Exertion
Temporary exertion on an ergometer (1W/kg body weight) (the effect of the intervention is fully and spontaneously reversible)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The within and between subject heat strain marker variability in relation to specific heat stress sources (ambient heat, ambient humidity, exertion, and clothing)
Time Frame: Max. 7 days
The primary endpoint is the within- and between- subject heat strain marker variability of HR, CBT, WSR, and LSR in relation to various heat stress sources (increased ambient temperature, increased relative humidity, and exertion, all without and with additional clothing.
Max. 7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Accuracy to detect the specific heat stress source (such as ambient heat, relative humidity) from different on- and in-body measurements
Time Frame: Max. 7 days
The models for the primary endpoints will be extended to explore the relationships between heat strain parameters, heat stress sources, as well as personal characteristics. Additionally, prediction of heat stress source will be explored.
Max. 7 days
Assessment of short-term heart rate variability in context to each heat stressor.
Time Frame: Max. 7 days
Short-term HRV with a repeating time frame of 5min. Root mean square of successive RR interval (RMSSD; in [ms]) and the Standard-deviation of RR intervals (SDRR; in [ms]) will be computed with respect to each heat stress source.
Max. 7 days
Temperature [°C] and relative humidity [%] of the microenvironment as an additional source of information for patterns to detect heat stressors
Time Frame: Max. 7 days
Features of temperature [°C] and relative humidity [%] of the microenvironment as additional model predictors.
Max. 7 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The relation between cognitive assessment and skin temperature
Time Frame: Max. 7 days
Correlation between subjective heat comfort (Visual Analog Scale, where +1 is comfortable and +4 is very uncomfortable) and baseline differential stress inventory (causes of stress, symptoms of stress, coping, stress stabilization) in relation to skin temperature [°C]
Max. 7 days
The relation between STROOP assessment and different heat stressors
Time Frame: Max. 7 days
Correlation between changes in the STROOP assessment outcome (number of errors and time of decision [ms], between beginning and end of heat stress exposure) in context to the various heat stress sources, skin temperature, and thermal comfort.
Max. 7 days
Novel Sweat Biomarkers for heat stress detection
Time Frame: Max. 7 days
Descriptive statistics for novel non-invasive biomarkers from sweat analysis with respect to heat stress source, including between- and within-subject variability
Max. 7 days
Recording heat strain parameters with an all-for-one device
Time Frame: Max. 7 days
The 'reliability' (missing data per minute ([%]) and the 'accuracy' (HR [bpm] with 95% confidence intervals), CBT (in [°C] with 95% confidence intervals), and local sweat rate measurements (in [g/h] with 95% confidence intervals) of the wearable device in recording vital parameters.
Max. 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ETH Zurich

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swiss Federal Office of Sports (BASPO)
Functional Genomics Center, ETH Zurich/University of Zurich
Center for Chronobiology, Psychiatric University Clinics, Basel
epyMetrics
Swiss Federal Railways
Innosuisse - Swiss Innovation Agency

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2022

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2023

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EKNZ ID: 2022 - 01325

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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