An interventional study of Control and Fan in Hyperthermia, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Basic science
The purpose of this study is to compare surface and intradermal skin temperature responses to heat stress with and without evaporative and convective cooling.
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.
478 studies on the registry are indexed under Hyperthermia; 92 are open to participants now.
This study's enrollment of 27 is below the median of 60 across 365 interventional studies indexed under Hyperthermia.
Browse Hyperthermia studies →University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.
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Exclusion Criteria:
Skin temperature measured in the intradermal space
Other: Control · Other: Fan · Other: Fan and Water Spray · Other: Water Spray
Skin temperature measured on the skin's surface using the same type of probe as that used in the intradermal space.
Other: Control · Other: Fan · Other: Fan and Water Spray · Other: Water Spray
Skin temperature measured on the skin's surface using a standard temperature probe
Other: Control · Other: Fan · Other: Fan and Water Spray · Other: Water Spray
Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.
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.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 20 minutes into the heat intervention.
| Milestone | Intradermal Skin Temperature Needle in Intradermal Skin Layer | Intradermal Skin Temperature Needle on Skin Surface | Skin Temperature Thermistor on Skin Surface |
|---|---|---|---|
| Started | 9 | 9 | 9 |
| Completed | 9 | 9 | 9 |
| Not completed | 0 | 0 | 0 |
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.
| Degree Centigrade | Intradermal Skin Temperature Needle in Intradermal Skin Layer | Intradermal Skin Temperature Needle on Skin Surface | Skin Temperature Thermistor on Skin Surface |
|---|---|---|---|
| Skin Temperature With Fan Only | 36.9 ± .5 | 37.8 ± .7 | 37.4 ± .5 |
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.
| Degree Centigrade | Intradermal Skin Temperature Needle in Intradermal Skin Layer | Intradermal Skin Temperature Needle on Skin Surface | Skin Temperature Thermistor on Skin Surface |
|---|---|---|---|
| Skin Temperature With Fan and Water Spray | 32.3 ± 1.5 | 30.8 ± 1.7 | 30.3 ± 2.2 |
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.
| Degree Centigrade | Intradermal Skin Temperature Needle in Intradermal Skin Layer | Intradermal Skin Temperature Needle on Skin Surface | Skin Temperature Thermistor on Skin Surface |
|---|---|---|---|
| Skin Temperature With Water Spray Only | 31.9 ± 1.4 | 30.6 ± 1.7 | 30.4 ± 1.3 |
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.
| Degree Centigrade | Intradermal Skin Temperature Needle in Intradermal Skin Layer | Intradermal Skin Temperature Needle on Skin Surface | Skin Temperature Thermistor on Skin Surface |
|---|---|---|---|
| Skin Temperature With No Cooling | 35.3 ± .6 | 36 ± .7 | 35.9 ± .5 |
Collected over 4 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intradermal Skin Temperature Needle in Intradermal Skin Layer | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Intradermal Skin Temperature Needle on Skin Surface | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Skin Temperature Thermistor on Skin Surface | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
| Age, Categorical(Participants) | Intradermal Skin Temperature Needle in Intradermal Skin Layer | Intradermal Skin Temperature Needle on Skin Surface | Skin Temperature Thermistor on Skin Surface | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 9 | 9 | 9 | 27 |
| >=65 years | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | Intradermal Skin Temperature Needle in Intradermal Skin Layer | Intradermal Skin Temperature Needle on Skin Surface | Skin Temperature Thermistor on Skin Surface | Total |
|---|---|---|---|---|
| Mean | 29 ± 4 | 29 ± 4 | 29 ± 4 | 29 ± 4 |
| Sex: Female, Male(Participants) | Intradermal Skin Temperature Needle in Intradermal Skin Layer | Intradermal Skin Temperature Needle on Skin Surface | Skin Temperature Thermistor on Skin Surface | Total |
|---|---|---|---|---|
| Female | 4 | 4 | 4 | 12 |
| Male | 5 | 5 | 5 | 15 |
| Race (NIH/OMB)(Participants) | Intradermal Skin Temperature Needle in Intradermal Skin Layer | Intradermal Skin Temperature Needle on Skin Surface | Skin Temperature Thermistor on Skin Surface | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 1 | 3 |
| White | 8 | 8 | 8 | 24 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Region of Enrollment(participants) | Intradermal Skin Temperature Needle in Intradermal Skin Layer | Intradermal Skin Temperature Needle on Skin Surface | Skin Temperature Thermistor on Skin Surface | Total |
|---|---|---|---|---|
| United States | 9 | 9 | 9 | 27 |
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University of Texas Southwestern Medical Center