UMIN-CTR Clinical Trial

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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