Trial Outcomes & Findings for Skin Surface and Intradermal Temperature Responses to Heat Stress (NCT NCT06593067)
NCT ID: NCT06593067
Last Updated: 2026-08-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
1 hour 20 minutes into the the heat intervention.
Results posted on
2026-08-14
Participant Flow
Participant milestones
| Measure |
Intradermal Skin Temperature Needle in Intradermal Skin Layer
Control: Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.
Fan: 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 Spray: 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 Spray: 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.
|
Intradermal Skin Temperature Needle on Skin Surface
Control: Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.
Fan: 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 Spray: 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 Spray: 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 Thermistor on Skin Surface
Control: Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.
Fan: 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 Spray: 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 Spray: 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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
9
|
|
Overall Study
COMPLETED
|
9
|
9
|
9
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Skin Surface and Intradermal Temperature Responses to Heat Stress
Baseline characteristics by cohort
| Measure |
Intradermal Skin Temperature Needle in Intradermal Skin Layer
n=9 Participants
Control: Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.
Fan: 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 Spray: 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 Spray: 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.
|
Intradermal Skin Temperature Needle on Skin Surface
n=9 Participants
Control: Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.
Fan: 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 Spray: 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 Spray: 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 Thermistor on Skin Surface
n=9 Participants
Control: Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.
Fan: 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 Spray: 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 Spray: 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.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=11 Participants
|
9 Participants
n=11 Participants
|
9 Participants
n=22 Participants
|
27 Participants
n=255 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
|
Age, Continuous
|
29 years
STANDARD_DEVIATION 4 • n=11 Participants
|
29 years
STANDARD_DEVIATION 4 • n=11 Participants
|
29 years
STANDARD_DEVIATION 4 • n=22 Participants
|
29 years
STANDARD_DEVIATION 4 • n=255 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=11 Participants
|
4 Participants
n=11 Participants
|
4 Participants
n=22 Participants
|
12 Participants
n=255 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=11 Participants
|
5 Participants
n=11 Participants
|
5 Participants
n=22 Participants
|
15 Participants
n=255 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=11 Participants
|
1 Participants
n=11 Participants
|
1 Participants
n=22 Participants
|
3 Participants
n=255 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=11 Participants
|
8 Participants
n=11 Participants
|
8 Participants
n=22 Participants
|
24 Participants
n=255 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=255 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=11 Participants
|
9 participants
n=11 Participants
|
9 participants
n=22 Participants
|
27 participants
n=255 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intradermal Skin Temperature Needle in Intradermal Skin Layer
n=9 Participants
Control: Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.
Fan: 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 Spray: 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 Spray: 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.
|
Intradermal Skin Temperature Needle on Skin Surface
n=9 Participants
Control: Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.
Fan: 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 Spray: 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 Spray: 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 Thermistor on Skin Surface
n=9 Participants
Control: Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.
Fan: 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 Spray: 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 Spray: 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
|
36.9 Degree Centigrade
Standard Deviation .5
|
37.8 Degree Centigrade
Standard Deviation .7
|
37.4 Degree Centigrade
Standard Deviation .5
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intradermal Skin Temperature Needle in Intradermal Skin Layer
n=9 Participants
Control: Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.
Fan: 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 Spray: 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 Spray: 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.
|
Intradermal Skin Temperature Needle on Skin Surface
n=9 Participants
Control: Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.
Fan: 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 Spray: 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 Spray: 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 Thermistor on Skin Surface
n=9 Participants
Control: Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.
Fan: 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 Spray: 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 Spray: 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 and Water Spray
|
32.3 Degree Centigrade
Standard Deviation 1.5
|
30.8 Degree Centigrade
Standard Deviation 1.7
|
30.3 Degree Centigrade
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intradermal Skin Temperature Needle in Intradermal Skin Layer
n=9 Participants
Control: Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.
Fan: 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 Spray: 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 Spray: 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.
|
Intradermal Skin Temperature Needle on Skin Surface
n=9 Participants
Control: Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.
Fan: 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 Spray: 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 Spray: 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 Thermistor on Skin Surface
n=9 Participants
Control: Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.
Fan: 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 Spray: 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 Spray: 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 Water Spray Only
|
31.9 Degree Centigrade
Standard Error 1.4
|
30.6 Degree Centigrade
Standard Error 1.7
|
30.4 Degree Centigrade
Standard Error 1.3
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Intradermal Skin Temperature Needle in Intradermal Skin Layer
n=9 Participants
Control: Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.
Fan: 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 Spray: 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 Spray: 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.
|
Intradermal Skin Temperature Needle on Skin Surface
n=9 Participants
Control: Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.
Fan: 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 Spray: 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 Spray: 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 Thermistor on Skin Surface
n=9 Participants
Control: Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.
Fan: 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 Spray: 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 Spray: 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 No Cooling
|
35.3 Degree Centigrade
Standard Deviation .6
|
36 Degree Centigrade
Standard Deviation .7
|
35.9 Degree Centigrade
Standard Deviation .5
|
Adverse Events
Intradermal Skin Temperature Needle in Intradermal Skin Layer
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Intradermal Skin Temperature Needle on Skin Surface
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Skin Temperature Thermistor on Skin Surface
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Craig Crandall, PhD
University of Texas Southwestern Medical Center
Phone: 214-345-4623
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place