UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040905 |
|---|---|
| Receipt number | R000046705 |
| Scientific Title | Analyses on longitudinal and cross-sectional influences of sleep quality for health outcomes by using NSSR data |
| Date of disclosure of the study information | 2020/06/25 |
| Last modified on | 2023/08/29 18:10:55 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Analyses on longitudinal and cross-sectional influences of sleep quality for health outcomes by using NSSR data
Acronym
Analyses on longitudinal and cross-sectional influences of sleep quality for health outcomes by using NSSR data
Scientific Title
Analyses on longitudinal and cross-sectional influences of sleep quality for health outcomes by using NSSR data
Scientific Title:Acronym
Analyses on longitudinal and cross-sectional influences of sleep quality for health outcomes by using NSSR data
Region
| Japan |
Condition
Condition
lifestyle diseases, depression and all-cause deaths
Classification by specialty
| Medicine in general | Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
pathological factors
Basic objectives2
Others
Basic objectives -Others
etiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sleep quality
Key secondary outcomes
sleep restfulness, sleep depth, total sleep time, sleep latency, wake after sleep onset, early-morning awakening, severity of insomnia, daytime sleepiness, indices of polysomnography, indices of actigraphy, health outcomes associates with lifestyle diseases and depression, and all-cause mortality, quality of life
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
participants in cohort studies of the NSRR
Key exclusion criteria
not applicable
Target sample size
28102
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
042-346-2071
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
https://www.nature.com/articles/s41598-021-03997-z
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-021-03997-z
Number of participants that the trial has enrolled
5804
Results
Among middle-aged adults, the lowest TST quartile with feeling unrested was associated with higher mortality: the highest TST quartile with feeling rested was associated with lower mortality. Among older adults, the highest TIB quartile with feeling unrested was associated with higher mortality.
Results date posted
| 2023 | Year | 08 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participants aged 40 years and older were enrolled from existing cohorts (the Sleep Heart Health Study (SHHS)) and underwent the baseline examination between 1995 and 1998.
Participant flow
All data were derived from the SHHS.
Adverse events
None
Outcome measures
all-cause mortality
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2020 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 07 | Month | 17 | Day |
Date trial data considered complete
| 2020 | Year | 07 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
NSRR data has been got transfer from the BRIGHAM AND WOMEN'S HOSPITAL (MA, USA).
Management information
Registered date
| 2020 | Year | 06 | Month | 25 | Day |
Last modified on
| 2023 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046705
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
