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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031144
Receipt No. R000035539
Scientific 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
Date of disclosure of the study information 2018/02/09
Last modified on 2018/07/06

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Basic information
Public 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
Acronym Study to verify the effect of sleep quality improvement effect and nighttime blood glucose level change by using 4-layer special three-dimensional mattress
Scientific 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Yoshikazu Yonei
Organization Faculty of Life and Medical Sciences,Doshisha University
Division name Anti-Aging Medical Research Center
Zip code
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
Middle name
Last name Toshiyasu Tamura
Organization TES Holdings Co., Ltd.
Division name Department of Clinical Trial
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2018 Year 01 Month 31 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000035539

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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