IEEM- Work:Rest Cycles in Burn Survivors- Humidity

NCT06966336 | Recruiting

• 1 other identifier: STU20250255
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in core temperature

  Change in core body temperature will be measured either from a temperature sensor pill or from a rectal thermometer.

  From the start of exercise to the end of the last rest period. Approximately at 0 and 170 minutes.

Secondary Outcomes (1)

• Change in Heart Rate

  From the start of exercise to the end of the last rest period. Approximately at 0 and 170 minutes.

Study Arms (6)

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.

Eligibility Criteria

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

Study Population

1. Non-burn control. 2. Individuals 20 - 40% of their body surface area burned. 3. Individuals with greater than 40% of their body surface area burned.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \- 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.
• \- 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 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.
• \- 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Texas Health Resources: collaborator

Study Sites (1)

IEEM Texas Health Presbyterian Hospital Dallas

Dallas, Texas, 75231, United States

RECRUITING

MeSH Terms

Conditions

Hyperthermia; Burns

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Craig Crandall, PhD

CONTACT

214-345-4623; craigcrandall@texashealth.org

Erin Harper, BS

CONTACT

214-345-4737; erinharper2@texashealth.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 11, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2031
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)