HyperthermiaNCT06593067
Skin Surface and Intradermal Temperature Responses to Heat Stress
A study testing Fan, Fan and Water Spray and Water Spray in people with Hyperthermia, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to compare surface and intradermal skin temperature responses to heat stress with and without evaporative and convective cooling. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperthermia
- What is being tested?
- Fan, Fan and Water Spray and Water Spray
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2024to 13 Nov 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Free of any significant underlying medical problems based upon a detailed medical history and physical exam.
- Normal resting electrocardiogram.
Who cannot join
- Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, etc.; as well as serious abnormalities detected on routine screening.
- Individuals who are pregnant, planning to become pregnant, or breastfeeding.
- Taking prescribed medications (such as beta blockers and non-dihydropyridine calcium channel blockers) or over-the-counter medications that have known influences on thermoregulatory response.
- Current smokers, as well as individuals who regularly smoked within the past 3 years.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Exercise and Environmental Medicine
Dallas, Texas, 75231
About this study
The purpose of this study is to compare surface and intradermal skin temperature responses to heat stress with and without evaporative and convective cooling.
Read the detailed description
Humans have important thermoregulatory responses aimed at maintaining body temperature within a narrow range. These responses are driven in part by receptors located in the skin that monitor temperature changes and provide feedback to the central nervous system. Given that skin temperature can affect the physiological responses to heat stress, it is important to accurately measure skin temperature in response to heat stress with and without evaporative (i.e., sweat) and convective (i.e., air flow) cooling. Skin temperature is most often measured on the surface of the skin; however, this temperature can be influenced by other factors such as the local environment. It is unclear how the temperature of the skins surface compares to the temperature within the dermal layer of the skin.
The study team will directly compare skin surface and intradermal temperature responses to heat stress and determine whether these responses area altered by evaporative or convective cooling methods. To accomplish this objective, healthy adults will be exposed to ambient heat stress (no higher than 47°C) with and without evaporative (water sprayed on the skin) and convective (electric fan) cooling. Thermoregulatory responses, inclusive of skin surface and intradermal temperatures, will be assessed throughout the heat trial.
- Conditions
- Hyperthermia
- Being tested
- Control, Fan, Fan and Water Spray, Water Spray
- Keywords
- Skin Temperature, Intradermal Temperature, Cooling Modalities
- Medical subject headings
- Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.
FanOther
Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes with an electric fan as a cooling modality.
Fan and Water SprayOther
Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes with an electric fan and water spray as cooling modalities.
Water SprayOther
Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes with water spray as a cooling modality.
| Study group | Role | What they receive |
|---|---|---|
| Intradermal Skin Temperature Needle in Intradermal Skin Layer | Active comparator | Skin temperature measured in the intradermal space Receives: Other: Control; Other: Fan; Other: Fan and Water Spray; Other: Water Spray |
| Intradermal Skin Temperature Needle on Skin Surface | Active comparator | Skin temperature measured on the skin's surface using the same type of probe as that used in the intradermal space. Receives: Other: Control; Other: Fan; Other: Fan and Water Spray; Other: Water Spray |
| Skin Temperature Thermocouple on Skin Surface | Active comparator | Skin temperature measured on the skin's surface using a standard temperature probe Receives: Other: Control; Other: Fan; Other: Fan and Water Spray; Other: Water Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin Temperature With Fan Only
Skin temperature will be measured from small temperature sensitive electrodes attached to the surface and intradermal layer of the skin of the participant with the fan cooling modality.
Measured: 40 minutes into the heat intervention.
Skin Temperature With Fan and Water Spray
Skin temperature will be measured from small temperature sensitive electrodes attached to the surface and intradermal layer of the skin of the participant with both the fan and water spray cooling modalities.
Measured: 60 minutes into the heat intervention.
Skin Temperature With Water Spray Only
Skin temperature will be measured from small temperature sensitive electrodes attached to the surface and intradermal layer of the skin of the participant with the water spray cooling modality.
Measured: 1 hour 20 minutes into the the heat intervention.
Skin Temperature With No Cooling
Skin temperature will be measured from small temperature sensitive electrodes attached to the surface and intradermal layer of the skin of the participant during the heat intervention with no cooling.
Measured: 20 minutes into the heat intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Oct 2024
- Primary completion13 Nov 2025
- Study completion13 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperthermiaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Craig Crandall, University of Texas Southwestern Medical Center
- Investigators
- Craig Crandall, Ph.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593067
- Sponsor's protocol ID
- STU_2024_0636
- Status last verified
- Aug 2026
- First submitted
- 6 Sep 2024
- Last updated
- 14 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Surface and Intradermal Temperature Responses to Heat Stress
- ClinicalTrials.gov ID
- NCT06593067
- Acronym / sponsor ID
- STU_2024_0636
- Conditions
- Hyperthermia
- Keywords
- Skin Temperature, Intradermal Temperature, Cooling Modalities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 13 Nov 2025 (actual)
- Study completion
- 13 Nov 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Posted 14 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare surface and intradermal skin temperature responses to heat stress with and without evaporative and convective cooling.
Detailed description
Humans have important thermoregulatory responses aimed at maintaining body temperature within a narrow range. These responses are driven in part by receptors located in the skin that monitor temperature changes and provide feedback to the central nervous system. Given that skin temperature can affect the physiological responses to heat stress, it is important to accurately measure skin temperature in response to heat stress with and without evaporative (i.e., sweat) and convective (i.e., air flow) cooling. Skin temperature is most often measured on the surface of the skin; however, this temperature can be influenced by other factors such as the local environment. It is unclear how the temperature of the skins surface compares to the temperature within the dermal layer of the skin.
The study team will directly compare skin surface and intradermal temperature responses to heat stress and determine whether these responses area altered by evaporative or convective cooling methods. To accomplish this objective, healthy adults will be exposed to ambient heat stress (no higher than 47°C) with and without evaporative (water sprayed on the skin) and convective (electric fan) cooling. Thermoregulatory responses, inclusive of skin surface and intradermal temperatures, will be assessed throughout the heat trial.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intradermal Skin Temperature Needle in Intradermal Skin Layer | Active comparator | Other: Control, Other: Fan, Other: Fan and Water Spray, Other: Water SpraySkin temperature measured in the intradermal space |
| Intradermal Skin Temperature Needle on Skin Surface | Active comparator | Other: Control, Other: Fan, Other: Fan and Water Spray, Other: Water SpraySkin temperature measured on the skin's surface using the same type of probe as that used in the intradermal space. |
| Skin Temperature Thermocouple on Skin Surface | Active comparator | Other: Control, Other: Fan, Other: Fan and Water Spray, Other: Water SpraySkin temperature measured on the skin's surface using a standard temperature probe |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Free of any significant underlying medical problems based upon a detailed medical history and physical exam.
- Normal resting electrocardiogram.
Key exclusion criteria (4 listed)
- Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, etc.; as well as serious abnormalities detected on routine screening.
- Individuals who are pregnant, planning to become pregnant, or breastfeeding.
- Taking prescribed medications (such as beta blockers and non-dihydropyridine calcium channel blockers) or over-the-counter medications that have known influences on thermoregulatory response.
- Current smokers, as well as individuals who regularly smoked within the past 3 years.
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 |
|---|---|---|
| ControlIndividuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality. | Other | Intradermal Skin Temperature Needle in Intradermal Skin Layer, Intradermal Skin Temperature Needle on Skin Surface, Skin Temperature Thermocouple on Skin Surface |
| FanIndividuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes with an electric fan as a cooling modality. | Other | Intradermal Skin Temperature Needle in Intradermal Skin Layer, Intradermal Skin Temperature Needle on Skin Surface, Skin Temperature Thermocouple on Skin Surface |
| Fan and Water SprayIndividuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes with an electric fan and water spray as cooling modalities. | Other | Intradermal Skin Temperature Needle in Intradermal Skin Layer, Intradermal Skin Temperature Needle on Skin Surface, Skin Temperature Thermocouple on Skin Surface |
| Water SprayIndividuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes with water spray as a cooling modality. | Other | Intradermal Skin Temperature Needle in Intradermal Skin Layer, Intradermal Skin Temperature Needle on Skin Surface, Skin Temperature Thermocouple on Skin Surface |
Primary outcome
Skin Temperature With Fan Only
Time frame: 40 minutes into the heat intervention.
Skin temperature will be measured from small temperature sensitive electrodes attached to the surface and intradermal layer of the skin of the participant with the fan cooling modality.
Skin Temperature With Fan and Water Spray
Time frame: 60 minutes into the heat intervention.
Skin temperature will be measured from small temperature sensitive electrodes attached to the surface and intradermal layer of the skin of the participant with both the fan and water spray cooling modalities.
Skin Temperature With Water Spray Only
Time frame: 1 hour 20 minutes into the the heat intervention.
Skin temperature will be measured from small temperature sensitive electrodes attached to the surface and intradermal layer of the skin of the participant with the water spray cooling modality.
Skin Temperature With No Cooling
Time frame: 20 minutes into the heat intervention.
Skin temperature will be measured from small temperature sensitive electrodes attached to the surface and intradermal layer of the skin of the participant during the heat intervention with no cooling.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Craig Crandall, Ph.D. principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fan, Fan and Water Spray and Water Spray in people with Hyperthermia, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 2 inclusion and 4 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 14 Aug 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 14 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Skin Temperature With Fan Only (time frame: 40 minutes into the heat intervention.). The study lists 4 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 14 Aug 2026.