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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+