UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024644 |
|---|---|
| Receipt number | 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 16:17:52 |
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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
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
info@tes-h.co.jp
Sponsor or person
Institute
Anti-Aging Bank 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028198
