UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029140 |
|---|---|
| Receipt number | 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 09:40:25 |
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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
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
ichiba.tomohisa@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033320
