UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059661 |
|---|---|
| Receipt number | R000068245 |
| Scientific Title | Evaluation of the effectiveness of hot and cold stimulation on cognitive task load |
| Date of disclosure of the study information | 2025/12/31 |
| Last modified on | 2025/11/06 10:21:26 |
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Basic information
Public title
Evaluation of the effectiveness of hot and cold stimulation on cognitive task load
Acronym
Evaluation of the effectiveness of hot and cold stimulation on cognitive task load
Scientific Title
Evaluation of the effectiveness of hot and cold stimulation on cognitive task load
Scientific Title:Acronym
Evaluation of the effectiveness of hot and cold stimulation on cognitive task load
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effectiveness of hot and cold stimulation on cognitive task load, and to explore physiological changes caused by cognitive task load.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Cognitive task results
Key secondary outcomes
-external auditory canal temperature
-skin temperature
-Body surface temperature
-Karolinska drowsiness scale
-VAS (Subjective Assessment Scale)
-Autonomic nervous system function
-Heart rate
-Flicker value
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Apply sheet formulation for approximately 65 minutes during the cognitive task and until the end of the study. -> washout period -> cognitive task only
Interventions/Control_2
cognitive task only -> washout period -> Apply sheet formulation for approximately 65 minutes during the cognitive task and until the end of the study.
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
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Person who feels head fatigue at work
Key exclusion criteria
1. Person who is currently undergoing treatment for a disease
2. Person who is currently taking medication
3. Pregnant or suspected to be pregnant
4. Person with sensitivity to cold
5. person who is uncomfortable with cold stimuli such as menthol stimulation
6. Person who has difficulty or is uncomfortable with the use of compresses
7. Person who does not like the smell of bergamot or mint
8. Person who has strong reactions to tape adhesive or alcohol-impregnated cotton for probe placement
9. Person who has difficulty responding to biological sex
10. Person who is already participating in other research studies at the time of receiving explanations about the research, or person who plans to participate in other research studies during the period of cooperation for participation in this study.
11. person who is deemed by the principal investigator to be unsuitable to participate in the research due to non-compliance or other reasons.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Junko |
| Middle name | |
| Last name | Kitano |
Organization
Kao Corporation
Division name
Human Health Care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-70-3300-8405
kitano.junko@kao.com
Public contact
Name of contact person
| 1st name | Ryuta |
| Middle name | |
| Last name | Mizushima |
Organization
Kao Corporation
Division name
Human Health Care Research Lab.
Zip code
131-8501
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 131-8501, JAPAN
TEL
+81-80-4092-3630
Homepage URL
mizushima.ryuta@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao 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
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-9064
morisaki.naoko@kao.com
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
| 2025 | Year | 12 | Month | 31 | 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
| 2025 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2025 | Year | 11 | Month | 06 | Day |
Last modified on
| 2025 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068245
