UMIN-CTR Clinical Trial

Basic information
Public title	The effects of sleep evaluation and behavior improvement supports on self-rated health and work productivity.
Acronym	The effects of sleep evaluation and behavior improvement supports on self-rated health and work productivity.
Scientific Title	The effects of sleep evaluation and behavior improvement supports on self-rated health and work productivity.
Scientific Title:Acronym	The effects of sleep evaluation and behavior improvement supports on self-rated health and work productivity.
Region	Japan

Condition
Condition	No (healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of sleep evaluation and behavior improvement supports on self-rated health and work productivity,based on sleep evaluation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	-Sleep satisfaction
Key secondary outcomes	-Subjective and objective sleep quality -Subjective health -Subjective and objective fatigue/stress -Subjective and objective work productivity

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food Behavior,custom Other
Interventions/Control_1	Sleep evaluation and behavoir improvement supports for 2 weeks.
Interventions/Control_2	no intervention.
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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	-Subjects who are full time daytime worker -Subjects who sleep at night everyday. -Subjects who understand the purpose and the plan of this study and consent to participate in the study.
Key exclusion criteria	-Subjects who work on the graveyard shift during study period. -Subjects who are not sleep properly because of mental disorder, physical disorder or drug usage. -Subjects who use a medicine related to sleep, fatigue or stress. -Subjects who cannot stop to intake a food or quasi drug related to sleep, fatigue or stress. -Subjects who have disease, who have to go to hospital routinely and who have to receive medical observation. -Subjects who are sleep apnea syndrome or have either a possibility or medical history of sleep apnea syndrome. -Subjects who are pregnant or lactating, or plan to become pregnant during the study period. -Subjects who are participating or plan to participate in any other clinical trial during the study period. -Subjects who are deemed inappropriate for this study by the principle investigator.
Target sample size	100

Research contact person
Last name of lead principal investigator	1st name Megumi Middle name Last name Aono
Organization	LION Corporation
Division name	Wellness research laboratories
Zip code	2560811
Address	100, Tajima, Odawara, Kanagawa, JAPAN
TEL	0465-49-4541
Email	meg-y@lion.co.jp

Public contact
1st name of contact person	1st name Megumi Middle name Last name Aono
Organization	LION Corporation
Division name	Wellness research laboratories
Zip code	2560811
Address	100, Tajima, Odawara, Kanagawa, JAPAN
TEL	0465-49-4541
Homepage URL
Email	meg-y@lion.co.jp

Sponsor
Institute	LION Corporation
Institute
Department

Funding Source
Organization	LION Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	RIKEN
Name of secondary funder(s)	Ministry of Economy, Trade and Industry

IRB Contact (For public release)
Organization	LION Corporation
Address	100, Tajima, Odawara, Kanagawa, JAPAN
Tel	0465-48-3211
Email	meg-y@lion.co.jp

Secondary IDs
Secondary IDs	YES
Study ID_1	K2018-031
Org. issuing International ID_1	RIKEN
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 26 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	109
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	2018 Year 10 Month 10 Day
Date of IRB	2018 Year 09 Month 12 Day
Anticipated trial start date	2018 Year 10 Month 26 Day
Last follow-up date	2019 Year 03 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 10 Month 25 Day
Last modified on	2019 Year 04 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039381