HyperthermiaNCT06966336
IEEM- Work:Rest Cycles in Burn Survivors- Humidity
An observational study of Hyperthermia and Burn Injury, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperthermia, Burn Injury
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2025to 1 Aug 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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):
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
IEEM Texas Health Presbyterian Hospital Dallas
Dallas, Texas, 75231
Erin Harper, BS, 214-345-4737, erinharper@texashealth.org
Courtney Kirby, RN, 214-345-6502, courtneykirby@texashealth.org
About this study
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.
Read the detailed description
Non-burned control participants and participants who experienced serious burns covering ≥20% of their body surface area will be investigated. Participants will undergo up to three work:rest cycles in the heat (via our environmental chamber) set to no higher than 40 °C. The work:rest cycle will comprise of 30 min of exercise that is followed by up to 20 min of rest, while staying in the heated conditions. Three consecutive work:rest cycles will be performed as illustrated in the protocol document. During one visit, this protocol will be performed in a low humidity state. During the other visit (randomized and crossover), this protocol will be performed in a high humidity state.
- Conditions
- Hyperthermia, Burn Injury
- Keywords
- Burn Survivor, Burn, humid, dry, core temperature, heat, body temperature
- Medical subject headings
- Hyperthermia, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in core temperature
Change in core body temperature will be measured either from a temperature sensor pill or from a rectal thermometer.
Measured: 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
Heart rate will be measured from ECG electrodes attached to the participant.
Measured: From the start of exercise to the end of the last rest period. Approximately at 0 and 170 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start15 Aug 2025
- Primary completion1 Aug 2030 (estimated)
- Study completion1 Aug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthermiaStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Health Resources
- Responsible party
- Principal investigator, Craig Crandall, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966336
- Sponsor's protocol ID
- STU20250255
- Status last verified
- Aug 2026
- First submitted
- 2 May 2025
- Last updated
- 2 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IEEM- Work:Rest Cycles in Burn Survivors- Humidity
- ClinicalTrials.gov ID
- NCT06966336
- Acronym / sponsor ID
- STU20250255
- Conditions
- Hyperthermia, Burn Injury
- Keywords
- Burn Survivor, Burn, humid, dry, core temperature, heat, body temperature
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Collaborators
- Texas Health Resources
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 1 Aug 2030 (estimated)
- Study completion
- 1 Aug 2031 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Non-burned control participants and participants who experienced serious burns covering ≥20% of their body surface area will be investigated. Participants will undergo up to three work:rest cycles in the heat (via our environmental chamber) set to no higher than 40 °C. The work:rest cycle will comprise of 30 min of exercise that is followed by up to 20 min of rest, while staying in the heated conditions. Three consecutive work:rest cycles will be performed as illustrated in the protocol document. During one visit, this protocol will be performed in a low humidity state. During the other visit (randomized and crossover), this protocol will be performed in a high humidity state.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Change in core body temperature will be measured either from a temperature sensor pill or from a rectal thermometer.
1 secondary outcome
Change in Heart Rate
Time frame: From the start of exercise to the end of the last rest period. Approximately at 0 and 170 minutes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperthermia and Burn Injury, run by University of Texas Southwestern Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Craig Crandall, PhD (214-345-4623, craigcrandall@texashealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.