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OpenTrials
Completed

NCT Number: 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94304, United States

About this study

Workers in a variety of US industries-construction workers, welders, farmers, firefighters, and warehouse workers among them-are at risk for hyperthermia during work, yet very few interventions are being developed to mitigate heat related organ injury, particularly when workers do not have obvious symptoms of heat related illness. The investigators plan to test whether two active cooling technologies can help mitigate hyperthermia and risk for kidney injury. This work will enhance worker safety using evidence-based technology.

To accomplish the aims of testing two active cooling interventions, the investigators plan to implement a case-cross over randomized control trial design at the work site conducted in partnership with an employer and with 30 workers at risk for hyperthermia. Over three sequential weeks, the investigators will measure rate of core temperature change (primary outcome). Secondary outcomes will include changes in kidney injury markers; changes in worker productivity; and worker acceptability of interventions.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18
  • Anticipated to be working in the same job category for the duration of the study
  • Able to communicate in English or Spanish

Exclusion criteria

  • Cannot provide informed consent
  • Weight less than 40 kg
  • Inability to swallow pills
  • Known history of having a pacemaker or ICD
  • Pregnancy as determined by self report and confirmed on Day 1
  • Gastrointestinal disorders (e.g., gastroparesis, prior surgery on GI tract with the exception of appendectomy or cholecystectomy, diverticulosis or inflammatory bowel disease)
  • Plan for an elective MRI in the 7 days post last planned pill ingestion

Treatment and study plan

Standard Heat Illness Prevention Measures

Behavioral

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

Cooling bandana

Other

Cooling bandana embedded with a polymer to slow evaporation

Cooling glove

Other

Cooling glove with ability to circulate cool water interface with palmar skin

Primary outcomes

  1. Core Temperature

    Time frame: up to 10 hours

    Rate of core temperature change as measured by core temperature pill

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
May 31, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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