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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024644
Receipt No. R000028198
Scientific Title Evaluation of Quality of Sleep and Antioxidation power and immunity power with mattress of Four-layer special three-dimensional structure
Date of disclosure of the study information 2016/11/01
Last modified on 2017/10/03

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Basic information
Public title Evaluation of Quality of Sleep and Antioxidation power and immunity power with mattress of Four-layer special three-dimensional structure
Acronym Evaluation of Quality of Sleep and Antioxidation power and immunity power with mattress of Four-layer special three-dimensional structure
Scientific Title Evaluation of Quality of Sleep and Antioxidation power and immunity power with mattress of Four-layer special three-dimensional structure
Scientific Title:Acronym Evaluation of Quality of Sleep and Antioxidation power and immunity power with mattress of Four-layer special three-dimensional structure
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 mattress of Four-layer special three-dimensional structure for Quality of sleep and Antioxidation power and Immunity power for 4 weeks usage.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Oxidative stress test (Week 0, Week 4)
Key secondary outcomes [1]Sleep-related hormone test (Week 0, Week 4)
[2]Immunity test (Week 0, Week 4)
[3]Inflammatory test (Week 0, Week 4)
[4]Japanese version of the Pittsburgh Sleep Quality Index (Week 0, Week 4)
[5]Anti-Aging QOL Common Questionnaire (Week 0, Week 4)

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 mattress of Four-layer special three-dimensional structure
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
[5]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
[6]Individuals who use a quilt
[7]Individuals by whom going to bed by a single person is possible using in the test duration and a test mattress
[8]Individuals whose written informed consent has been obtained
[9]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 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
[9]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day)
[10]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months
[11]Individuals whose life style will change during the test period (ex. a night shift, travel for a long time, job transfer)
[12]Individuals who participated in other clinical studies in the past three months
[13]Individuals who are or are posslibly, or are lactating
[14]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
Institute Anti-Aging Bank Co.,Ltd.
Institute
Department

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 医療法人社団和啓会 メディクス本郷クリニック

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.toukastress.jp/webj/article/2017/GS17-18.pdf
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
2016 Year 10 Month 19 Day
Date of IRB
Anticipated trial start date
2016 Year 10 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
2016 Year 10 Month 31 Day
Last modified on
2017 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028198

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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