UMIN-CTR Clinical Trial

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
Email	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
Email	info@tes-h.co.jp

Sponsor
Institute	Anti-Aging Bank Co.,Ltd.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041906