HyperthermiaNCT06998667
Cooling Solutions for Outdoor Workers
A study testing Standard Heat Illness Prevention Measures, Cooling bandana and Cooling glove in people with Hyperthermia and Heat Acclimation and Thermotolerance, run by Stanford University at 1 site in United States.
Trial summary
The investigators aim to test the effectiveness of two cooling interventions in reducing the core temperature of outdoor workers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperthermia, Heat Acclimation and Thermotolerance
- What is being tested?
- Standard Heat Illness Prevention Measures, Cooling bandana and Cooling glove
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2025to 5 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Anticipated to be working in the same job category for the duration of the study
- Able to communicate in English or Spanish
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The investigators aim to test the effectiveness of two cooling interventions in reducing the core temperature of outdoor workers.
Read the detailed description
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.
- Conditions
- Hyperthermia, Heat Acclimation and Thermotolerance
- Being tested
- Standard Heat Illness Prevention Measures, Cooling bandana, Cooling glove
- Keywords
- outdoor work, heat stress, kidney injury, cooling interventions
- Medical subject headings
- Hyperthermia, Heat Stress Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Heat Illness Prevention MeasuresBehavioural
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 bandanaOther
Cooling bandana embedded with a polymer to slow evaporation
Cooling gloveOther
Cooling glove with ability to circulate cool water interface with palmar skin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Behavioral: Standard Heat Illness Prevention Measures; Other: 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 Receives: Behavioral: Standard Heat Illness Prevention Measures; Other: Cooling glove |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core Temperature
Rate of core temperature change as measured by core temperature pill
Measured: up to 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start24 Jun 2025
- Primary completion25 Jul 2025
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperthermiaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julie Parsonnet, Stanford University
- Investigators
- Shuchi Anand, MD, Principal investigator, Stanford UniversityJulie Parsonnet, MD, Principal investigator, Stanford UniversityMaria Montez Rath, mrath@stanford.edu, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998667
- Sponsor's protocol ID
- 80246
- Status last verified
- Jun 2025
- First submitted
- 20 May 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At the moment we plan to reserve individual participant data for current project only
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cooling Solutions for Outdoor Workers
- ClinicalTrials.gov ID
- NCT06998667
- Acronym / sponsor ID
- 80246
- Conditions
- Hyperthermia, Heat Acclimation and Thermotolerance
- Keywords
- outdoor work, heat stress, kidney injury, cooling interventions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 31 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to test the effectiveness of two cooling interventions in reducing the core temperature of outdoor workers.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Heat Illness Prevention | Active comparator | Behavioral: Standard Heat Illness Prevention MeasuresStandard 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 Measures | Experimental | Behavioral: Standard Heat Illness Prevention Measures, Other: Cooling bandanaProvision of a bandana with slow-evaporation polymer for use during work, in addition to standard CAL-OSHA workplace heat illness prevention interventions |
| Cooling glove with standard Heat Illness Prevention | Experimental | Behavioral: Standard Heat Illness Prevention Measures, Other: Cooling gloveProvision of a glove with ability to circulate cool water, for use during breaks, in addition to standard CAL-OSHA workplace heat illness prevention interventions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18
- Anticipated to be working in the same job category for the duration of the study
- Able to communicate in English or Spanish
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Heat Illness Prevention MeasuresStandard 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 | Behavioural | Cooling bandana with Standard Heat Illness Prevention Measures, Cooling glove with standard Heat Illness Prevention, Standard Heat Illness Prevention |
| Cooling bandanaCooling bandana embedded with a polymer to slow evaporation | Other | Cooling bandana with Standard Heat Illness Prevention Measures |
| Cooling gloveCooling glove with ability to circulate cool water interface with palmar skin | Other | Cooling glove with standard Heat Illness Prevention |
Primary outcome
Core Temperature
Time frame: up to 10 hours
Rate of core temperature change as measured by core temperature pill
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No. At the moment we plan to reserve individual participant data for current project only
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuchi Anand, MD principal investigator
Stanford University
Julie Parsonnet, MD principal investigator
Stanford University
Maria Montez Rath, mrath@stanford.edu principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Heat Illness Prevention Measures, Cooling bandana and Cooling glove in people with Hyperthermia and Heat Acclimation and Thermotolerance, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core Temperature (time frame: up to 10 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.