UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040904 |
|---|---|
| Receipt number | R000046704 |
| Scientific Title | Influence of sleep quality for lifestyle diseases and depression |
| Date of disclosure of the study information | 2020/06/25 |
| Last modified on | 2020/06/25 20:50:20 |
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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
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
kenichik@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046704
