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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029140
Receipt No. R000033320
Scientific Title Effects of Local Cutaneous Warming on body Temperature and Sleep
Date of disclosure of the study information 2017/10/06
Last modified on 2018/10/09

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Basic information
Public title Effects of Local Cutaneous Warming on body Temperature and Sleep
Acronym Effects of cutaneous warming on body temperature
Scientific Title Effects of Local Cutaneous Warming on body Temperature and Sleep
Scientific Title:Acronym Effects of cutaneous warming on body temperature
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Dermatology Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the body temperature and sleep by applying local cutaneous warming for healthy male
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of the cutaneous temperature by applying local cutaneous warming
Key secondary outcomes Evaluation of the EEG, heart rate subjective report by applying local cutaneous warming

Base
Study type Interventional

Study design
Basic design Factorial
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment Other
Interventions/Control_1 1.Sleep diary for 6 days
2.Treatment of local warming
3.Sleep diary for 6 days
4.Treatment of placebo
Interventions/Control_2 1.Sleep diary for 6 days
2.Treatment of placebo
3.Sleep diary for 6 days
4.Treatment of local warming
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
59 years-old >=
Gender Male
Key inclusion criteria General good health without receiving some clinical treatment
Key exclusion criteria 1.Shift worker
2.Evidence of sleep disorder
3.habitual sleep time <5 h or >9h
4.Strongly sleepiness for a daytime
5.Smoker
6.Taking medicines
7.No attachment of EEG, ECG, or rectal temperature
8.Demonstrate any of the following conditions on the eyes or skin around eyes; inflammation, visible irritation, rash, swelling, eczema, or any other abnormalities
9.Are sensitive to thermal sense
10.Patients who are assessed as inadequate as the object of this clinical study
Target sample size 24

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kyoko Tagami
Organization Kao Corporation
Division name Personal Health Care Research
Zip code
Address 2-1-3, Bunka Sumida-ku Tokyo 131-8501, Japan
TEL +81-3-5630-7271
Email tagami.kyoko@kao.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohisa Ichiba
Organization Kao Corporation
Division name Personal Health Care Research
Zip code
Address 2-1-3, Bunka Sumida-ku Tokyo 131-8501, Japan
TEL +81-3-5630-7271
Homepage URL
Email ichiba.tomohisa@kao.co.jp

Sponsor
Institute Kao Corporation
Institute
Department

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
Address
Tel
Email

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
2017 Year 10 Month 06 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
2017 Year 09 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 14 Day
Last modified on
2018 Year 10 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033320

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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