UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052373 |
|---|---|
| Receipt number | R000059780 |
| Scientific Title | Impact of sleep problems on loneliness and suicidal ideation: A cohort study |
| Date of disclosure of the study information | 2023/10/02 |
| Last modified on | 2023/10/02 12:55:48 |
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Basic information
Public title
Impact of sleep problems on loneliness and suicidal ideation: A cohort study
Acronym
Impact of sleep problems on loneliness and suicidal ideation: A cohort study
Scientific Title
Impact of sleep problems on loneliness and suicidal ideation: A cohort study
Scientific Title:Acronym
Impact of sleep problems on loneliness and suicidal ideation: A cohort study
Region
| Japan |
Condition
Condition
sleep problem
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to examine a 3-year cohort study about the impact of sleep problems on loneliness and suicidal ideation.
Basic objectives2
Others
Basic objectives -Others
cohort study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Athens Insomnia Scale (AIS; Okajima et al., 2013)
The Circadian Energy Scale (CIRENS; Ottoni et al., 2011)
Subjective sleep variables: Bedtime and wake-up time on weekday and weekend, and real and ideal total sleep time
Three-Item Loneliness Scale (TILS; Igarashi, 2019)
Suicide index: Self-harm, suicidal ideation, suicide planning, and suicidal impulsivity and control
Key secondary outcomes
Lubben Social Network Scale (LSNS-6; Kurimoto et al., 2011)
Ford Insomnia Response to Stress Test (FIRST; Nakajima et al., 2014)
Restorative Sleep Questionnaire (RSQ; Itaba et al., 2023)
GAD-7 and PHQ-9 (Muramatsu et al., 2014)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Community people who have consented to this survey
Key exclusion criteria
Community people who did not give their consent to this survey
Community people under 18 years of age
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | ISA |
| Middle name | |
| Last name | OKAJIMA |
Organization
Tokyo Kasei Univeristy
Division name
Faculty of Humanities
Zip code
173-8602
Address
1-18-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL
03-3961-5276
okajima-i@tokyo-kasei.ac.jp
Public contact
Name of contact person
| 1st name | ISA |
| Middle name | |
| Last name | OKAJIMA |
Organization
Tokyo Kasei Univeristy
Division name
Faculty of Humanities
Zip code
173-8602
Address
1-18-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL
03-3961-5276
Homepage URL
okajima-i@tokyo-kasei.ac.jp
Sponsor or person
Institute
Tokyo Kasei University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Tokyo Kasei Univeristy
Address
1-18-1 Kaga, Itabashi-ku, Tokyo, Japan
Tel
03-3961-5276
okajima-i@tokyo-kasei.ac.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
| 2023 | Year | 10 | Month | 02 | 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
| 2023 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Since this is a three-year cohort study, the survey will be conducted three times, in 2023, 2024, and 2025.
Management information
Registered date
| 2023 | Year | 10 | Month | 02 | Day |
Last modified on
| 2023 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059780
