UMIN-CTR Clinical Trial

Basic information
Public title	Influence of sleep quality for lifestyle diseases and depression
Acronym	Influence of sleep quality for lifestyle diseases and depression
Scientific Title	Influence of sleep quality for lifestyle diseases and depression
Scientific Title:Acronym	Influence of sleep quality for lifestyle diseases and depression
Region	Japan

Condition
Condition	lifestyle diseases and depression
Classification by specialty	Medicine in general Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	pathological factor
Basic objectives2	Others
Basic objectives -Others	etiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	sleep quality score, systolic and diastolic blood pressures, blood glucose level, HbA1c level, total cholesterol level, serum triglyceride level, high-density and low-density lipoprotein cholesterol levels, depression total score, stress total score
Key secondary outcomes	scores of drinking, smoking, exercise, and dietary habits, and scores in hematological examinations, biochemical tests, urine examinations, and medical checkups

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	participants of the cohort study in Tohoku from 2013 to 2016 conducted by ToMMo (Tohoku Medical Megabank Organization)
Key exclusion criteria	not applicable
Target sample size	67000

Research contact person
Name of lead principal investigator	1st name Kenichi Middle name Last name Kuriyama
Organization	National Center of Neurology and Psychiatry
Division name	Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code	187-8553
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL	0423461986
Email	kenichik@ncnp.go.jp

Public contact
Name of contact person	1st name Kenichi Middle name Last name Kuriyama
Organization	National Center of Neurology and Psychiatry
Division name	Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code	187-8553
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo
TEL	042-346-2071
Homepage URL
Email	kenichik@ncnp.go.jp

Sponsor
Institute	National Center of Neurology and Psychiatry
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Committee of National Center of Neurology and Psychiatry
Address	4-1-1 Ogawa-Higashi, Kodaira, Tokyo
Tel	042-341-2712
Email	rinri-jimu@ncnp.go.jp

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	2020 Year 06 Month 25 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	Preinitiation
Date of protocol fixation	2020 Year 01 Month 24 Day
Date of IRB	2020 Year 03 Month 02 Day
Anticipated trial start date	2020 Year 07 Month 15 Day
Last follow-up date	2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	getting transfer from ToMMo

Management information
Registered date	2020 Year 06 Month 25 Day
Last modified on	2020 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046704