UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036774 |
|---|---|
| Receipt number | R000041906 |
| Scientific Title | Study to verify how the use of the test mattress has an effect on skin quality, sleep quality and fatigue |
| Date of disclosure of the study information | 2019/05/17 |
| Last modified on | 2019/10/03 12:27:00 |
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Basic information
Public title
Study to verify how the use of the test mattress has an effect on skin quality, sleep quality and fatigue
Acronym
Study to verify how the use of the test mattress has an effect on skin quality, sleep quality and fatigue
Scientific Title
Study to verify how the use of the test mattress has an effect on skin quality, sleep quality and fatigue
Scientific Title:Acronym
Study to verify how the use of the test mattress has an effect on skin quality, sleep quality and fatigue
Region
| Japan |
Condition
Condition
Healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to verify the effect of using test bedding (4-layer special three-dimensional mattress "AiR SX") on skin quality, sleep quality and fatigue.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The stratum corneum water content,The transepidermal water loss,The skin elasticity,VISIA,(Week 0, Week 4, Week 8)
Key secondary outcomes
OSA sleep inventory MA version,Japanese version of the Pittsburgh Sleep Quality Index,Questionnaire on fatigue(VAS),Salivary cortisol,(Week 0, Week 4, Week 8)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Use 4-layer special three-dimensional mattress
Interventions/Control_2
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
| 40 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Female
Key inclusion criteria
[1]Japanese females aged 40-59 years
[2]Individuals who are healthy and are not received treatment of disease
[3]Individuals who are concerned about skin dryness and stiffness
[4]Individuals who are not satisfy quality of sleep
[5]Individuals whose sleeping hours are over 4 hours from lights-out to rising and time of lights-out and rising is regular and bedtime is every 24th hours
[6]Individuals whose written informed consent has been obtained
[7]Individuals who can come to the designated examination date and receive the examination
[8]Individuals judged appropriate for the study by the principal
Key exclusion criteria
[1]Individuals using medical products
[2]Individuals with skin disease, such as atopic dermatitis
[3]Individuals who have an inflammation or a scar on a measuring area
[4]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders
[5]Individuals with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.)
[6]Individuals who are suspected, recived treatment of, or have a history of sleep apnea syndrome
[7]Individuals who have or are suspected with the night urination, prostatomegaly, or overactive bladder
[8]Individuals receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache, menstrual pain, common cold, etc.
[9]Individuals with >=25.0kg/m2 BMI
[10]Individuals who have the possibility of developing seasonal allergic symptoms such as hay fever and the possibility of using medicines (eyedrops, nose drops are acceptable)
[11]Individuals who have a regular intake of supplements and health food products that have an effect on skin quality improvement and fatigue, and individuals who are scheduled to take it during the test period (but not applicable to those who can stop taking it at the time of obtaining consent)
[12]Individuals who have a habit of taking alcohol
[13]Individuals with alcoholism or other mental disorders
[14]Individuals whose life style will change during the test period (ex. travel for a long time)
etc.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Yoshikazu |
| Middle name | |
| Last name | Yonei |
Organization
Faculty of Life and Medical Sciences,Doshisha University
Division name
Anti-Aging Medical Research Center
Zip code
6100394
Address
1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL
0774-65-6394
yyonei@mail.doshisha.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Tamura |
Organization
TES Holdings Co., Ltd.
Division name
Department of Clinical Trial
Zip code
1100015
Address
6F,Kairaku Bldg,2-7-5 Higashi-Ueno,Taitou-ku,Tokyo
TEL
03-6801-8400
Homepage URL
info@tes-h.co.jp
Sponsor or person
Institute
Anti-Aging Bank Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
Nishikawa Co., Ltd.
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
Society of Glycative Stress Research
Address
5F-11,Musashino Bldg,2-13-10 Shinjuku,Shinjuku-ku,Tokyo
Tel
03-6709-8842
rinri-glycativestress@antiaging-bank.com
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
うえのあさがおクリニック
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 05 | Month | 17 | 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
12
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
| 2019 | Year | 04 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 26 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 05 | Month | 16 | Day |
Last modified on
| 2019 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041906
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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