NCT06998667

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 31, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

June 24, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2026

Completed
Last Updated

April 29, 2026

Status Verified

June 1, 2025

Enrollment Period

1 month

First QC Date

May 20, 2025

Last Update Submit

April 23, 2026

Conditions

Keywords

outdoor workheat stresskidney injurycooling interventions

Outcome Measures

Primary Outcomes (1)

  • Core Temperature

    Rate of core temperature change as measured by core temperature pill

    up to 10 hours

Study Arms (3)

Standard Heat Illness Prevention

ACTIVE COMPARATOR

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.

Behavioral: Standard Heat Illness Prevention Measures

Cooling bandana with Standard Heat Illness Prevention Measures

EXPERIMENTAL

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

Behavioral: Standard Heat Illness Prevention MeasuresOther: Cooling bandana

Cooling glove with standard Heat Illness Prevention

EXPERIMENTAL

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

Behavioral: Standard Heat Illness Prevention MeasuresOther: Cooling glove

Interventions

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 with Standard Heat Illness Prevention MeasuresCooling glove with standard Heat Illness PreventionStandard Heat Illness Prevention

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

Cooling glove with standard Heat Illness Prevention

Cooling bandana embedded with a polymer to slow evaporation

Cooling bandana with Standard Heat Illness Prevention Measures

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

HyperthermiaHeat Stress Disorders

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Shuchi Anand, MD

    Stanford University

    PRINCIPAL INVESTIGATOR
  • Julie Parsonnet, MD

    Stanford University

    PRINCIPAL INVESTIGATOR
  • Maria Montez Rath, mrath@stanford.edu

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Emeritus in Medicine

Study Record Dates

First Submitted

May 20, 2025

First Posted

May 31, 2025

Study Start

June 24, 2025

Primary Completion

July 25, 2025

Study Completion

January 5, 2026

Last Updated

April 29, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

At the moment we plan to reserve individual participant data for current project only

Locations