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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043805
Receipt No. 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

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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
Email 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
Email fukuchi473@eps.co.jp

Sponsor
Institute EP Mediate Co., Ltd.
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050003

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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