How heat and humidity affect core temperature during work-rest cycles in burn survivors
Official title: IEEM- Work:Rest Cycles in Burn Survivors- Humidity
Run by University of Texas Southwestern Medical Center · NCT06966336 · Data updated 2026-11-12
This project will test whether heat and humidity change core body temperature during repeated 30-minute exercise and rest cycles in adults who had major burns (≥20% body surface) and in non-burned controls.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 70 (estimated) |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | August 15, 2025 |
| Main results expected | August 1, 2030 |
| Study ends | August 1, 2031 |
| Registry record updated | September 2, 2026 |
| Trial ID | NCT06966336 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 who either had a serious burn covering ≥20% of their body surface area (up to about 40%) or healthy adults without major medical problems who meet screening criteria.
✕Probably not a fit
People with unstable heart disease, uncontrolled chronic conditions, recent smokers, BMI ≥31 kg/m2, or those with very recent or extremely large burns or other exclusions listed by the investigators likely will not benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with serious burns covering at least 20% of their body surface and healthy non-burned control participants will complete up to three consecutive work:rest cycles in an environmental chamber set to no higher than 40 °C. Each cycle includes 30 minutes of exercise followed by up to 20 minutes of rest while remaining in the heated environment. Participants return for a randomized crossover visit so the protocol is performed once in low humidity and once in high humidity. Continuous core temperature and related physiological measures will be recorded to compare responses between burn and control groups and between humidity conditions.
Why it matters
Potential benefit: If successful, results could help improve safety guidance and heat-exposure recommendations for burn survivors during work, exercise, or hot-weather activities.
How similar studies have gone: Previous research has shown that severe burns can alter temperature regulation, but direct randomized crossover comparisons of low versus high humidity during work:rest cycles in burn survivors are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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IEEM Texas Health Presbyterian Hospital Dallas
Dallas, Texas, United States Recruiting
Study contacts
- Study coordinator: Craig Crandall, PhD
- Email: craigcrandall@texashealth.org
- Phone: 214-345-4623
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.