UMIN-CTR Clinical Trial

Public title

Evaluation of Quality of Sleep with SEIATSU (R) Mattress

Acronym

Evaluation of Quality of Sleep with SEIATSU (R) Mattress

Scientific Title

Evaluation of Quality of Sleep with SEIATSU (R) Mattress

Scientific Title:Acronym

Evaluation of Quality of Sleep with SEIATSU (R) Mattress

Region

Japan

Condition

N/A (healthy adults or adults with sleep disorder)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study examine effect of MUATSU (R) mattress for quality of sleep for 4 weeks usage.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Sleep-related hormone test (Week 0, Week 4)
[2]Oxidative stress test (Week 0, Week 4)
[3]Hormone metabolism and production test (Week 0, Week 4)
[4]Endocrine system test (Week 0, Week 4)
[5]Lipid metabolism test (Week 0, Week 4)
[6]Glycometabolism test (Week 0, Week 4)
[7]Liver function test (Week 0, Week 4)
[8]Nitrogenous constituents test (Week 0, Week 4)
[9]Electrolyte test (Week 0, Week 4)
[10]Protein test (Week 0, Week 4)
[11]Anemia test (Week 0, Week 4)
[12]Japanese version of the Pittsburgh Sleep Quality Index (Screening, Week 0, Week 4)
[13]OSA sleep inventory (Week 0, Week 4)
[14]Anti-Aging QOL Common Questionnaire (Week 0, Week 4)
[15]Sleep evaluation with sleepscan (Week 0, Week 4)

Key secondary outcomes

[1]Blood pressure, pulsation (Screening, Week 0, Week 4)
[2]Weight, body fat percentage, BMI (Screening, Week 0, Week 4)
[3]Doctor's questions (Screening, Week 0, Week 4)
[4]Subject's diary (From 7 days before using a test material to the last day of the test)

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Using of SEIATSU (R) mattress (4 weeks)

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

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 whose BMI is 18.5-25.0
[4]Individuals who are not satisfy quality of sleep (ex. insomnia, interrupted sleep, early morning awakening, sleep disorder)
[5]Individuals whose sleeping hours are over 4 hours from lights-out to rising
[6]Individuals whose time of lights-out and rising is regular and bedtime is every 24th hours
[7]Individuals who use a quilt
[8]Individuals who can use a test mattress during the test period
[9]Individuals who can sleep by him/herself during sleep evaluation period
[10]Individuals whose written informed consent has been obtained
[11]Individuals judged appropriate for the study by the principal

Key exclusion criteria

[1]Individuals using medical products
[2]Individuals who are suspected, recived treatment of, or have a history of sleep apnea syndrome
[3]Individuals who have or are suspected with the night urination, prostatomegaly, or overactive bladder
[4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease
[5]Individuals with skin disease, such as atopic dermatitis
[6]Individuals who have a history of hepatitis
[7]Individuals with serious anemia
[8]Individuals whose systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg
[9]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplyments in the past 3 month or will ingest those foods during the test period
[10]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day)
[11]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months
[12]Individuals whose life style will change during the test period (ex. a night shift, travel for a long time, job transfer)
[13]Individuals who participated in other clinical studies in the past three months
[14]Individuals who are or are posslibly, or are lactating
[15]Individuals judged inappropriate for the study by the principal

Target sample size

12

Name of lead principal investigator

1st name
Middle name
Last name	Yoshikazu Yonei

Organization

Doshisha University

Division name

Graduate School of Life and Medical Sciences

Zip code

Address

1-3 Tatara Miyakodani Kyotanabe City Kyoto, 610-0394, Japan

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

TES Holdings 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

Date of disclosure of the study information

2015

Year

12

Month

01

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

2015

Year

10

Month

17

Day

Date of IRB

Anticipated trial start date

2015

Year

11

Month

21

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

12

Month

01

Day

Last modified on

2016

Year

05

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023023