UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of Local Cutaneous Warming on body Temperature and Sleep
Title of the study (Brief title)	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	Kyoko Tagami
Organization	Kao Corporation
Division name	Personal Health Care Research
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	Tomohisa Ichiba
Organization	Kao Corporation
Division name	Personal Health Care Research
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 09 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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