UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043805 |
|---|---|
| Receipt number | R000050003 |
| Scientific Title | Preliminary study about the association of the quality improvement of the sleep and health status |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2021/04/01 16:40:35 |
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Basic information
Public title
Preliminary study about the association of the quality improvement of the sleep and health status
Acronym
Preliminary study about the association of the quality improvement of the sleep and health status
Scientific Title
Preliminary study about the association of the quality improvement of the sleep and health status
Scientific Title:Acronym
Preliminary study about the association of the quality improvement of the sleep and health status
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To inspect influence on health by the improvement of the quality of the sleep by using a sleep improvement program together with a health food for 12 weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Quality of the sleep by the sleep improvement program (awake time, deep sleep %)
Key secondary outcomes
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of test food daily intake, for 12 weeks.
Participate in a sleep improvement program for 12 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Subjects who agree in writing to study participation and can inspect on predetermined inspection day
(2) Subjects who are smartphone user, and use the bedclothing to get sleep data
Key exclusion criteria
(1) Subjects who were under treatment or have a history of serious diseases(e.g., diabetes, liver disease, kidney disease, or heart disease)
(2) Subjects who have a disease that requires constant medication, subjects with serious diseases that require medication, and subjects who have history
(3) Subjects who have history of mental illness (depression, etc.), chronic fatigue syndrome, insomnia, hypersomnia, circadian rhythm sleep disorder, parasomnia, etc
(4) Subjects who are under treatment of sleep apnea syndrome
(5) Subjects who are judged as unsuitable for the use environment based on the results of sleep improvement program
(6) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(7) Subjects who have experienced abnormal clinical test values or cardiopulmonary function and have been judged to have problems participating in the study
(8) Subjects at risk of developing allergy in relation to the study
(9) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(10) Subjects who have participated in other clinical study within the last one month prior to the current study
(11) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
(12) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Mihoko |
| Middle name | |
| Last name | Kurokawa |
Organization
Q'SAI CO., LTD.
Division name
Research and Development Department
Zip code
810-8588
Address
1-1-1 Yakuin, Chuo-ku, Fukuoka-shi, Japan
TEL
092-724-0855
kurokawa@kyusai.co.jp
Public contact
Name of contact person
| 1st name | Saki |
| Middle name | |
| Last name | Fukuchi |
Organization
EP Mediate Co., Ltd.
Division name
Development Business Headquarters, TTC Center, Trial Planning Department
Zip code
162-0822
Address
Turuya Bldg.,2-23, Shimomiyabicho, Shinjuku-ku, Tokyo
TEL
03-5657-4983
Homepage URL
fukuchi473@eps.co.jp
Sponsor or person
Institute
EP Mediate Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
non-disclosure
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
Haradoi hospital
Address
6-40-8 Aoba, Higashi-ku, Fukuoka-shi, Fukuoka
Tel
092-691-3881
irb@haradoi-hospital.com
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
| 2021 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 01 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 19 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 04 | Month | 01 | Day |
Last modified on
| 2021 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050003
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
