UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060050 |
|---|---|
| Receipt number | R000068672 |
| Scientific Title | Establishment of a Cognitive and Visual Fatigue Model Associated with Passive Heating |
| Date of disclosure of the study information | 2025/12/11 |
| Last modified on | 2025/12/11 10:54:43 |
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Basic information
Public title
Establishment of a Cognitive and Visual Fatigue Model Associated with Passive Heating
Acronym
Establishment of a Visual Cognitive Fatigue Model Associated with Heating
Scientific Title
Establishment of a Cognitive and Visual Fatigue Model Associated with Passive Heating
Scientific Title:Acronym
Establishment of a Visual Cognitive Fatigue Model Associated with Heating
Region
| Japan |
Condition
Condition
Health young adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a fatigue model for cognitive and visual functions associated with passive increases in body temperature.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Esophageal Temperature,Gas Parameters,Thermal Sensation,Thermal Comfort,Latency,Correct rate,Amplitude,Peak Saccadic Velocity,Gain,Accuracy
Key secondary outcomes
Skin Temperature,Blood Pressure,Heart Rate,Pupil Diameter,Blink Rate,Urine Specific Gravity
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
1-hour Hot Water Immersion (41.5 degrees Celsius)
Interventions/Control_2
1-hour Thermal Neutral Water Immersion (34.5 degrees Celsius)
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
Healthy undergraduate or graduate students who express interest in the study and voluntarily apply to participate. Eligible participants must have no respiratory, dermatological, or visual impairments, and must have no habitual medication use or smoking history.
Key exclusion criteria
Individuals with respiratory or dermatological diseases, visual impairments, or a history of regular medication use or smoking.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yuma |
| Middle name | |
| Last name | Suzaki |
Organization
Graduate School of Niigata University of Health and Welfare
Division name
Department of Health and Sports
Zip code
9503198
Address
Shimamicho 1398, Kita-ku, Niigata city, Niigata
TEL
08027247145
wtm25007@nuhw.ac.jp
Public contact
Name of contact person
| 1st name | Yuma |
| Middle name | |
| Last name | Suzaki |
Organization
Graduate School of Niigata University of Health and Welfare
Division name
Department of Health and Sports
Zip code
9503198
Address
Shimamicho 1398, Kita-ku, Niigata city, Niigata
TEL
08027247145
Homepage URL
wtm25007@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
Graduate School of Niigata University of Health and Welfare
Address
Shimamicho 1398, Kita-ku, Niigata city, Niigata
Tel
08027247145
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
| 2025 | Year | 12 | Month | 11 | 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
Anticipated trial start date
| 2025 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2030 | 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
| 2025 | Year | 12 | Month | 11 | Day |
Last modified on
| 2025 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068672
