UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031144 |
|---|---|
| Receipt number | 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 12:07:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
info@tes-h.co.jp
Sponsor or person
Institute
Anti-Aging Bank Co.,Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035539
