UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061998 |
|---|---|
| Receipt number | R000070281 |
| Scientific Title | A Study on the Effect of Cooling Devices in Firefighting Operations on Suppressing Core Body Temperature and Reducing the Risk of Heat Stroke |
| Date of disclosure of the study information | 2026/06/22 |
| Last modified on | 2026/06/22 08:41:55 |
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Basic information
Public title
A Study on the Effect of Cooling Devices in Firefighting Operations on Suppressing Core Body Temperature and Reducing the Risk of Heat Stroke
Acronym
A Study on Cooling Devices Used During Firefighting Operations
Scientific Title
A Study on the Effect of Cooling Devices in Firefighting Operations on Suppressing Core Body Temperature and Reducing the Risk of Heat Stroke
Scientific Title:Acronym
A Study on Cooling Devices Used During Firefighting Operations
Region
| Japan |
Condition
Condition
Heat Stroke
Classification by specialty
| Medicine in general | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effects of localized cooling of the neck and forearms on firefighters during firefighting operations and rest periods. With the cooperation of the Osaka City Fire Department, we will conduct a comprehensive evaluation by measuring physiological indicators (vital signs such as core body temperature), cognitive and psychological indicators (cognitive function tests, voice emotion analysis), and subjective indicators (rating of perceived exertion) of active-duty firefighters in a combustion test environment simulating actual firefighting operations.
The significance of this study lies in identifying simple and effective localized cooling methods applicable during firefighting operations, which can contribute to on-site implementation as measures to reduce the risk of heatstroke. Furthermore, this study will clarify the effects of localized cooling interventions not only on physical recovery but also on the restoration of cognitive and mental functions, thereby contributing to the development of scientifically grounded safety management methods and injury prevention measures for firefighters.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Core body temperature, skin temperature, inner ear temperature, heart rate, sweat output
Key secondary outcomes
Cognitive function (accuracy and response time on the Stroop test), voice emotion, rating of perceived exertion (Borg scale score)
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Chest and back cooling using cooling vests (with ice packs)* during firefighting operations
*: Cooling vests routinely used by the Osaka City Fire Department
Interventions/Control_2
Combined use of Peltier-type cooling devices for neck cooling during firefighting operations and rest periods, and for forearm cooling during rest periods
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Current fire department personnel
2. Individuals who have undergone a routine health examination (including a comprehensive health screening) within the past year
3. Individuals who have received a thorough explanation of the purpose, content, and risks of this study and have provided written consent
Key exclusion criteria
1. Individuals with a history or current diagnosis of hypertension, heart disease, respiratory disease, kidney disease, diabetes, or similar conditions
2. Individuals currently taking medications that affect body temperature regulation or circulatory function
3. Individuals with abnormalities or medical conditions at the site where the measurement device will be attached
4. Individuals for whom the principal investigator determines are unsuitable based on the medical interview and vital sign check conducted on the day of the experiment, due to fever, lack of sleep, excessive fatigue, residual alcohol, or other factors
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Ebara |
Organization
University of Occupational and Environmental Health
Division name
Department of Ergonomics, Institute of Industrial Ecological Sciences
Zip code
807-8555
Address
1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka, Japan
TEL
093-691-7458
j-ninko@mbox.med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Shimpei |
| Middle name | |
| Last name | Yamada |
Organization
University of Occupational and Environmental Health
Division name
Department of Occupational Safety and Health Management, School of Health Sciences
Zip code
807-8555
Address
1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka, Japan
TEL
093-691-7153(4799)
Homepage URL
sin-y@health.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health
Institute
Department
Personal name
Funding Source
Organization
MORITA HOLDINGS CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University Ethics Committee, University of Occupational and Environmental Health
Address
1-1, Iseigaoka, Yahatanishi-ku Kitakyushu-shi, Fukuoka, Japan
Tel
093-603-1611
daigakurinri@mbox.pub.uoeh-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 22 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 06 | Month | 22 | Day |
Last modified on
| 2026 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070281
