UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032656 |
|---|---|
| Receipt number | R000037237 |
| Scientific Title | Observational study on changes in the surface temperature of the ear lobe against the environmental temperature in hot environment and fatigue |
| Date of disclosure of the study information | 2018/06/19 |
| Last modified on | 2019/11/21 08:11:41 |
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Basic information
Public title
Observational study on changes in the surface temperature of the ear lobe against the environmental temperature in hot environment and fatigue
Acronym
Characteristics of ear lobe surface Temperature changes under Thermal Environment
Scientific Title
Observational study on changes in the surface temperature of the ear lobe against the environmental temperature in hot environment and fatigue
Scientific Title:Acronym
Characteristics of ear lobe surface Temperature changes under Thermal Environment
Region
| Japan |
Condition
Condition
healthy subject
Classification by specialty
| Hepato-biliary-pancreatic surgery | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Correlation between tympanic membrane temperature and caudal surface temperature is observed by observing changes in eardrum temperature and tempo surface temperature in hot environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ear lobe temperature
Only during measurement.
Key secondary outcomes
Tympanic temperature, , heart rate, respiratory rate.body weight, ingested water content
Only during measurement.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Environment temperature.
Only for 2 hour measurement.
Interventions/Control_2
Cooling around the auricle.
Up to 1 hour only during intervention.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy men and women
Key exclusion criteria
Prohibited from exercising person.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Nagatomi |
| Middle name | |
| Last name | Ryoichi |
Organization
Tohoku University
Division name
Biomedical engineering
Zip code
9800845
Address
2-1 Seiryo-machi Aoba-ku Sendai-shi Miyagi-ken, Japan
TEL
0227522206
keizo@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Sato |
| Middle name | |
| Last name | Keizo |
Organization
Tohoku University
Division name
Biomedical Engineering
Zip code
9800845
Address
468-1-403 Aramaki Aoba Aoba-ku Sendai 980-0845, Japan
TEL
022-752-2206
Homepage URL
keizo@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Japan science and technology agency, Center of innovation
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Taisei rotec corporation
Nichiei intech corp.
Takenaka koumuten corp.
ObayashiCorp.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University
Address
2-1 Seiryo Aobaku Sendai-shi Miyagi-ken Japan
Tel
022-728-4105
keizo@med.tohoku.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
東北大学レジリエント社会構築イノベーションセンター/Tohoku University Innovation Center for Creation of a Resilient Society.
東北福祉大学体育館/Tohoku Fukushi University gymnasium
大成ロテック（株）プラント/Taisei Rotec Corp.plant.
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 19 | 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
Completed
Date of protocol fixation
| 2018 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2021 | 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
| 2018 | Year | 05 | Month | 21 | Day |
Last modified on
| 2019 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037237
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
