Skin Surface and Intradermal Temperature Responses to Heat Stress

NCT06593067 | Active Not Recruiting FDA Device

• 1 other identifier: STU_2024_0636
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperthermia

Keywords

Skin Temperature; Intradermal Temperature; Cooling Modalities

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  20 minutes into the heat intervention.

Study Arms (3)

Intradermal Skin Temperature Needle in Intradermal Skin Layer

ACTIVE COMPARATOR

Other: Control; Other: Fan; Other: Fan and Water Spray; Other: Water Spray

Intradermal Skin Temperature Needle on Skin Surface

ACTIVE COMPARATOR

Other: Control; Other: Fan; Other: Fan and Water Spray; Other: Water Spray

Skin Temperature Thermistor on Skin Surface

ACTIVE COMPARATOR

Other: Control; Other: Fan; Other: Fan and Water Spray; Other: Water Spray

Interventions

Control OTHER

Individuals will be exposed to a heated environment (41°C, 15% humidity) for a period of 15 minutes without a cooling modality.

Intradermal Skin Temperature Needle in Intradermal Skin Layer; Intradermal Skin Temperature Needle on Skin Surface; Skin Temperature Thermistor on Skin Surface

Fan OTHER

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.

Intradermal Skin Temperature Needle in Intradermal Skin Layer; Intradermal Skin Temperature Needle on Skin Surface; Skin Temperature Thermistor on Skin Surface

Fan and Water Spray OTHER

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.

Intradermal Skin Temperature Needle in Intradermal Skin Layer; Intradermal Skin Temperature Needle on Skin Surface; Skin Temperature Thermistor on Skin Surface

Water Spray OTHER

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 in Intradermal Skin Layer; Intradermal Skin Temperature Needle on Skin Surface; Skin Temperature Thermistor on Skin Surface

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Free of any significant underlying medical problems based upon a detailed medical history and physical exam.
• Normal resting electrocardiogram.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Institute for Exercise and Environmental Medicine

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Hyperthermia

Interventions

CCP110 protein, human

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heat Stress Disorders; Wounds and Injuries

Study Officials

• Craig Crandall, Ph.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Internal Medicine

Study Record Dates

• First Submitted: September 6, 2024
• First Posted: September 19, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)