UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062701 |
|---|---|
| Receipt number | R000071789 |
| Scientific Title | The Effect of Improved Temperature Sensation by Menthol Application on Cognitive Function During Hyperthermia |
| Date of disclosure of the study information | 2026/08/27 |
| Last modified on | 2026/08/26 17:37:37 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The Effect of Improved Temperature Sensation by Menthol Application on Cognitive Function During Hyperthermia
Acronym
The Effect of Improved Temperature Sensation by Menthol Application on Cognitive Function During Hyperthermia
Scientific Title
The Effect of Improved Temperature Sensation by Menthol Application on Cognitive Function During Hyperthermia
Scientific Title:Acronym
The Effect of Improved Temperature Sensation by Menthol Application on Cognitive Function During Hyperthermia
Region
| Japan |
Condition
Condition
Healthy Adult
Classification by specialty
| Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of the improvement in the sensation of warmth resulting from the application of menthol on cognitive function during passive elevation of body temperature
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Body weight, skin temperature, sublingual temperature, oesophageal temperature, respiratory gas parameters (such as oxygen consumption and ventilation), heart rate, thermal perception, thermal comfort, water intake, visual function (task accuracy, pupil diameter, etc.)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Aapplying either (1) the control solution or (2) the menthol solution
Interventions/Control_2
Immersion in warm water at 41.5 degree Celsius for one hour
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
| 18 | years-old | <= |
Age-upper limit
| 35 | years-old | >= |
Gender
Male
Key inclusion criteria
Participants must have no respiratory or skin conditions or visual impairments, and must not be taking any regular medication or have a history of smoking
Key exclusion criteria
Individuals with respiratory or skin conditions, visual impairments, or a history of taking regular medication or smoking
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yuma |
| Middle name | |
| Last name | Suzaki |
Organization
Niigata University of Health and Welfare Graduate School
Division name
Faculty of Health Sciences, Department of Health and Sports Studies
Zip code
950-3198
Address
1398 Shimami-cho, Kita Ward, Niigata City, Niigata Prefecture
TEL
025-257-4455
info@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Tomomi |
| Middle name | |
| Last name | Fujimoto |
Organization
Niigata University of Health and Welfare Graduate School
Division name
Faculty of Health Sciences, Department of Health and Sports Studies
Zip code
950-3198
Address
1398 Shimami-cho, Kita Ward, Niigata City, Niigata Prefecture
TEL
025-257-4455
Homepage URL
info@nuhw.ac.jp
Sponsor or person
Institute
Niigata University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Niigata University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University of Health and Welfare Graduate School
Address
1398 Shimami-cho, Kita Ward, Niigata City, Niigata Prefecture
Tel
025-257-4455
wtm25007@nuhw.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 | 08 | Month | 27 | 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 | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2036 | Year | 08 | Month | 01 | 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 | 08 | Month | 26 | Day |
Last modified on
| 2026 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071789
