UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Quality of Sleep with SEIATSU (R) Mattress
Title of the study (Brief title)	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)

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yoshikazu Yonei
Organization	Doshisha University
Division name	Graduate School of Life and Medical Sciences
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	Toshiyasu Tamura
Organization	TES Holdings Co., Ltd.
Division name	Department of Clinical Trial
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	TES Holdings Co., Ltd.
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 17 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023023