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IEEM- Work:Rest Cycles in Burn Survivors- Humidity

IEEM- Work:Rest Cycles in Burn Survivors- Humidity

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06966336
Enrollment
70
Registered
2025-05-11
Start date
2025-08-15
Completion date
2031-08-01
Last updated
2026-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn Injury, Hyperthermia

Keywords

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

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.

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.

Interventions

None listed

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER
Texas Health Resources
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in core temperatureFrom 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.

Secondary

MeasureTime frameDescription
Change in Heart RateFrom the start of exercise to the end of the last rest period. Approximately at 0 and 170 minutes.Heart rate will be measured from ECG electrodes attached to the participant.

Countries

United States

Contacts

CONTACTCraig Crandall, PhD
craigcrandall@texashealth.org214-345-4623
CONTACTErin Harper, BS
erinharper2@texashealth.org214-345-4737

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 3, 2026