Recruiting

Observational Study

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06966336

Conditions

Hyperthermia

Burn Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Study Details

Brief summary:

The purpose of this project is to identify the effects of a severe burn injuries in humans on core temperature responses during work:rest cycles while in a heated environment.

Conditions

Hyperthermia

Burn Injury

Study ID

NCT06966336

Start date

Aug 15, 2025

Status verified date

Aug, 2026

Completion date

Aug 1, 2031

Anticipated

Primary completion date

Aug 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria for Non-burned Individuals:

  • Participants must be free of any significant underlying medical problems based upon a detailed medical history and physical exam, and normal resting electrocardiogram. Participants must be between the ages of 18 and 65.

Exclusion Criteria for Non-burned Individuals:

  • Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, lung disease, etc.; as well as serious abnormalities detected on routine screening. Current smokers, as well as individuals who regularly smoked within the past 3 years will be excluded. Participants may also be excluded if body mass index is ≥ 31 kg/m2 will likewise be excluded. Participants must not have had a serious burn injury requiring more than 1 night stay in the hospital.

Inclusion Criteria for Individuals with up to 40% of their body surface area burned (moderate burn group):

\- Participants must be free of any significant underlying medical problems based upon a detailed medical history and physical exam, and normal resting electrocardiogram. Participants who have sustained a burn injury must have a burn covering 20-40% of their body surface area and 50% of those burns must be full-thickness burns requiring skin grafts. Participants must be between the ages of 18 and 65.

Exclusion Criteria for Individuals with up to 40% of their body surface area burned (moderate burn group):

\- Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, lung disease, etc.; as well as serious abnormalities detected on routine screening. Current smokers, as well as individuals who regularly smoked within the past 3 years will be excluded. Participants may also be excluded if body mass index is ≥ 31 kg/m2 will likewise be excluded.

Inclusion Criteria for Individuals with greater than 40% of their body surface area burned (large burn group):

\- Participants must be free of any significant underlying medical problems based upon a detailed medical history and physical exam, and normal resting electrocardiogram. Participants who have sustained a burn injury must have a burn covering more than 40% of their body surface area and 50% of those burns must be full-thickness burns requiring skin grafts. Participants must be between the ages of 18 and 65.

Exclusion Criteria for Individuals with greater than 40% of their body surface area burned (large burn group):

\- Known heart disease; other chronic medical conditions requiring regular medical therapy including cancer, diabetes, neurological diseases, and uncontrolled hypertension, lung disease, etc.; as well as serious abnormalities detected on routine screening. Current smokers, as well as individuals who regularly smoked within the past 3 years will be excluded. Participants may also be excluded if body mass index is ≥ 31 kg/m2 will likewise be excluded.

Study Design

Enrollment

70 participants

Anticipated

Interventions and Outcome Measures

Arms

Non-Burned Individuals in Low Humidity Environment

Non-burned individuals will perform up to three work:rest cycles in a heated environment with low humidity, with each work:rest cycle lasting up to 50 minutes.

Moderate Burned Individuals in Low Humidity Environment

Individuals with moderate sized burn injuries will perform up to three work:rest cycles in a heated environment with low humidity, with each work:rest cycle lasting up to 50 minutes.

Large Burned Individuals in Low Humidity Environment

Individuals with large sized burn injuries will perform up to three work:rest cycles in a heated environment with low humidity, with each work:rest cycle lasting up to 50 minutes.

Non-Burned Individuals in High Humidity Environment

Non-burned individuals will perform up to three work:rest cycles in a heated environment with high humidity, with each work:rest cycle lasting up to 50 minutes.

Moderate Burned Individuals in High Humidity Environment

Individuals with moderate sized burn injuries will perform up to three work:rest cycles in a heated environment with high humidity, with each work:rest cycle lasting up to 50 minutes.

Large Burned Individuals in HIgh Humidity Environment

Individuals with large sized burn injuries will perform up to three work:rest cycles in a heated environment with high humidity, with each work:rest cycle lasting up to 50 minutes.

Primary outcome measure

  • Change in core temperature [ Time Frame: From the start of exercise to the end of the last rest period. Approximately at 0 and 170 minutes. ]

Central Contacts and Locations

Locations

IEEM Texas Health Presbyterian Hospital Dallas

Recruiting

Dallas, Texas, United States, 75231

Contacts

Principal Investigator:

Craig Crandall, PhD

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

  • Burn Survivor
  • Burn
  • humid
  • dry
  • core temperature
  • heat
  • body temperature

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2026-09-02.