UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020017
Receipt number R000023023
Scientific Title Evaluation of Quality of Sleep with SEIATSU (R) Mattress
Date of disclosure of the study information 2015/12/01
Last modified on 2016/05/10 09:01:49

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Basic information

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

Condition

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

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

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



Assessment

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)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

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



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 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


Research contact person

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


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 or person

Institute

TES Holdings 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


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



Other administrative information

Date of disclosure of the study information

2015 Year 12 Month 01 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

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name