UMIN-CTR Clinical Trial

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

Healthy volunteer

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

Basic design

Cross-over

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Anti-Aging Bank Co.,Ltd.

Institute

Department

Personal name

Organization

Nishikawa Sangyo Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

医療法人社団　同済会 えみクリニック東大前（東京都）

Date of disclosure of the study information

2018

Year

02

Month

09

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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