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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032656
Receipt No. 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 2019/05/22

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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
Email 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
Email keizo@med.tohoku.ac.jp

Sponsor
Institute Tohoku University
Institute
Department

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
Email 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 Open public recruiting
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 05 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037237

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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