- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06593067
Skin Surface and Intradermal Temperature Responses to Heat Stress
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Dallas, Texas, United States, 75231
- Institute for Exercise and Environmental Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Free of any significant underlying medical problems based upon a detailed medical history and physical exam.
- Normal resting electrocardiogram.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Intradermal Skin Temperature Needle in Intradermal Skin Layer
|
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.
|
|
Active Comparator: Intradermal Skin Temperature Needle on Skin Surface
|
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.
|
|
Active Comparator: Skin Temperature Thermistor on Skin Surface
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
40 minutes into the heat intervention.
|
|
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.
|
60 minutes into the heat intervention.
|
|
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.
|
1 hour 20 minutes into the the heat intervention.
|
|
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.
|
20 minutes into the heat intervention.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Craig Crandall, Ph.D., UT Southwestern Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STU_2024_0636
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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