Cooling Solutions for Hyperthermia

Overseen By Shuchi Anand, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Pacemaker, Pregnancy, Gastrointestinal disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two cooling methods to determine their effectiveness in lowering the core temperature of people working outdoors in the heat. One group will use a special cooling bandana, while another will try a cooling glove during breaks. Both groups will follow standard heat safety measures. The goal is to identify which cooling method is most effective in maintaining coolness. The trial seeks outdoor workers who expect to remain employed for the study's duration and can speak English or Spanish. As an unphased trial, this study offers participants the opportunity to contribute to important research that could enhance heat safety for outdoor workers.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators.

What prior data suggests that these cooling interventions are safe for outdoor workers?

Research has shown that cooling bandanas, which use special cooling materials, effectively and safely provide relief from heat. Once soaked in water, they can keep users cool for up to four hours. No reports of negative effects have emerged from using these bandanas, making them a well-tolerated choice for staying cool.

Specific safety information for the cooling glove is not available. The trial phase is "Not Applicable," indicating it might be an early-stage study or testing something other than drugs. This suggests that detailed safety information might not be ready yet. Cooling gloves generally help reduce heat exposure and are usually considered safe when used as directed.

Overall, both the cooling bandana and glove appear to be safe options for managing heat. Participants should always check with the trial organizers and follow their guidance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these cooling solutions for hyperthermia because they offer innovative ways to manage body temperature during heat exposure. Unlike standard treatments that mainly focus on providing shade and cool water, the cooling bandana uses a slow-evaporation polymer to help keep workers cool while they work. The cooling glove, on the other hand, circulates cool water to enhance the cooling effect during breaks. These methods are designed to integrate seamlessly with existing heat illness prevention measures, potentially providing more immediate and effective relief from heat stress.

What evidence suggests that this trial's cooling interventions could be effective for hyperthermia?

This trial will compare different cooling solutions for managing hyperthermia. Studies have shown that cooling bandanas, one of the treatments in this trial, can quickly alleviate heat by using a special material that stays cool for up to four hours. Agricultural workers have reported positive experiences with these bandanas, finding them useful during long hours in the sun. Another treatment option in this trial is cooling gloves. Research on cooling gloves indicates they can lower body temperature and improve recovery after exercise by circulating cool water through the gloves. Some studies suggest that gloves can cool the body faster than resting alone. Both cooling bandanas and gloves have shown promising results in managing high body temperatures, especially in hot working conditions. ^{2 6 7 8 9}

Who Is on the Research Team?

Julie Parsonnet, MD

Principal Investigator

Stanford University

Shuchi Anand, MD

Principal Investigator

Stanford University

Maria Montez Rath, [e-mail]

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for outdoor workers over 18 who expect to stay in their job during the study and can communicate in English or Spanish. They must weigh more than 40 kg and not be pregnant, have a pacemaker/ICD, trouble swallowing pills, plans for an MRI soon after the study, or serious GI disorders.

Inclusion Criteria

Anticipated to be working in the same job category for the duration of the study

I can communicate in English or Spanish.

I am 18 years old or older.

Exclusion Criteria

Inability to swallow pills

Known history of having a pacemaker or ICD

Pregnancy as determined by self report and confirmed on Day 1

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive cooling interventions, including a cooling bandana and glove, over three weeks to test effectiveness in reducing core temperature

3 weeks

On-site monitoring during work hours

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on kidney injury markers and worker productivity

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cooling Solutions

Trial Overview

The trial tests if cooling gloves and bandanas help lower body temperature better than standard heat illness prevention methods among outdoor workers exposed to high temperatures.

How Is the Trial Designed?

Group I: Cooling glove with standard Heat Illness Prevention Experimental Treatment 2 Interventions

Provision of a glove with ability to circulate cool water, for use during breaks, in addition to standard CAL-OSHA workplace heat illness prevention interventions

Group II: Cooling bandana with Standard Heat Illness Prevention Measures Experimental Treatment 2 Interventions

Provision of a bandana with slow-evaporation polymer for use during work, in addition to standard CAL-OSHA workplace heat illness prevention interventions

Group III: Standard Heat Illness Prevention Active Control 1 Intervention

Standard CAL-OSHA workplace heat illness prevention interventions, which require availability of cool, potable water; availability of shade when temperatures exceed 80F; and encouragement of rest for cool down breaks.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06998667

NCT06998667 | Cooling Solutions for Outdoor Workers

The investigators aim to test the effectiveness of two cooling interventions in reducing the core temperature of outdoor workers. ... The investigators plan to ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8363586/

Cooling Interventions Among Agricultural Workers: Qualitative ...

Qualitatively data from 61 agricultural workers provided details of their perceptions and experiences with cooling interventions.

3.

ergodyne.com

ergodyne.com/chill-its-6710-cooling-bandana-polymers-tie-closure

Chill-Its 6710 Cooling Bandana - Polymers, Tie Closure

INSTANT COOLING RELIEF - Polymer cooling technology quickly activates for up to four hours of relief from the heat · EASY ACTIVATION - Soak in water for 2-5 ...

4.

dovepress.com

dovepress.com/efficacy-of-cooling-blankets-and-cold-fluid-infusions-in-classic-heats-peer-reviewed-fulltext-article-JIR

Efficacy of Cooling Blankets and Cold Fluid Infusions in ...

These results indicate that early rapid cooling improves heart and kidney functions and reduces inflammatory responses without causing prolonged ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11646365/

Practical Considerations for Using Personal Cooling ...

This systematic review sought to assess the physiological and perceptual effects of PCGs on workers in standard work clothing performing moderate‐to‐heavy ...

6.

ergodyne.com

ergodyne.com/chill-its-6700-cooling-headband-polymers-tie-closure

Chill-Its 6700 Cooling Headband - Polymers, Tie Closure

EASY ACTIVATION - Soak in water for 2-5 minutes; COOLING RELIEF - Polymer cooling technology quickly activates for up to four hours of relief from the heat ...

7.

safetyvestsandmore.com

safetyvestsandmore.com/products/ergodyne-evaporative-cooling-bandana-headband-6700?srsltid=AfmBOooUWm7tcDz1VMLVkMlTOKQ2kNlJVa1yXZI0gVBNaSdQeaaM6D4s

Ergodyne Evaporative Cooling Bandana Headband - 6700

Polymer cooling technology quickly activates for up to four hours of relief from the heat; Low Profile – For no-bulk wear under hard hats; 100% cotton bandana ...

8.

webstaurantstore.com

webstaurantstore.com/cooling-bandana-tie-lime/87912397.html?srsltid=AfmBOor6rlhPdJjD-Xa4ySGIbUAP9SNALXchBQOLd3SU6qLtzN5zrUh3

Ergodyne Chill-Its 6702 Lime Evaporative Cooling ...

This bandana is designed to regulate the body temperature and reduce the risk of heat-related illness by offering a simple, renewable solution to excessive heat ...

9.

jendcosafety.com

jendcosafety.com/ergodyne-chill-its-6700-evaporative-cooling-bandana-headband-polymers-tie-closure/?srsltid=AfmBOorgJeRoXzXlLAtFn1D5gexnGXb0dKL4P76l6NhMk-2BiEEXvrJZ

Ergodyne Chill-Its 6700 Evaporative Cooling Bandana ...

COOLING RELIEF - Polymer cooling technology quickly activates for up to four hours of relief from the heat · LOW-PROFILE - For no-bulk wear under hard hats ...