Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-31 @ 6:06 PM
Study NCT ID:
NCT06998667
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-07-03
First Post:
2025-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cooling Solutions for Outdoor Workers
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Cooling Solutions for Outdoor Workers
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: