UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study to verify the effect of sleep quality improvement effect and nighttime blood glucose level change by using 4-layer special three-dimensional mattress
Title of the study (Brief title)	Study to verify the effect of sleep quality improvement effect and nighttime blood glucose level change by using 4-layer special three-dimensional mattress
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 sleep quality improvement effect and the nighttime blood glucose level change by using 4-layer special three-dimensional mattress.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Night of the blood glucose level,AUC
Key secondary outcomes	[1]Sleep-related hormone test (Week 0, Week 2) [2] OSA sleep inventory MA version (Week 0, Week 2) [3]Japanese version of the Pittsburgh Sleep Quality Index (Week 0, Week 2)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	[1]Use 4-layer special three-dimensional mattress [2]Use control products
Interventions/Control_2	[1]Use control products [2]Use 4-layer special three-dimensional mattress
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	[1]Japanese males and females aged 40-65 years [2]Individuals who are healthy and are not received treatment of disease [3]Individuals who are not satisfy quality of sleep [4]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 [5]Dinner was completed 3 hours before bedtime, after that, individuals with no snacking habits until getting up [6]Individuals working on weekdays only 5 days a day during the daytime [7]Individuals whose written informed consent has been obtained [8]Individuals who can come to the designated examination date and receive the examination [9]Individuals judged appropriate for the study by the principal
Key exclusion criteria	[1]Individuals using medical products [2]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders [3]Individuals who are suspected, recived treatment of, or have a history of sleep apnea syndrome [4]Individuals who have or are suspected with the night urination, prostatomegaly, or overactive bladder [5]Individuals receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache, menstrual pain, common cold, etc. [6]Individuals with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.) [7]Individuals with history of gastrointestinal disorders except for appendicitis [8]Individuals with >=25.0kg/m2 BMI [9]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [10]Individuals who have experienced mood disorder or condition deterioration due to blood sampling in the past [11]Individuals deemed sensitive to the test product or highly allergic to foods or medical drugs [12]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) [13]Individuals who continuously ingest supplements that have effects on blood glucose levels and supplements that contain vitamin C and those who intend to consume during the study period (but not those who can stop taking the intake at the time of consent acquisition) [14]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day) [15]Individuals whose life style will change during the test period (ex. travel for a long time) [16]Individuals who are or are posslibly, or are lactating [17]Individuals with a scheduled or likely to visit an MRI examination during the period of this study etc.
Target sample size	12

Research contact person
Name of lead principal investigator	Yoshikazu Yonei
Organization	Faculty of Life and Medical Sciences,Doshisha University
Division name	Anti-Aging Medical Research Center
Address	1-3 Tatara Miyakodani,Kyotanabe City,Kyoto
TEL	0774-65-6394
Email	yyonei@mail.doshisha.ac.jp

Public contact
Name of contact person	Toshiyasu Tamura
Organization	TES Holdings Co., Ltd.
Division name	Department of Clinical Trial
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL	03-6801-8480
Homepage URL
Email	info@tes-h.co.jp

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

Funding Source
Organization	Nishikawa Sangyo Co., Ltd.
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	医療法人社団　同済会 えみクリニック東大前（東京都）

Other administrative information
Date of disclosure of the study information	2018 Year 02 Month 09 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 31 Day
Anticipated trial start date	2018 Year 02 Month 09 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	2018 Year 02 Month 05 Day
Last modified on	2018 Year 07 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035539