UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045528 |
|---|---|
| Receipt number | R000051837 |
| Scientific Title | A survey for Japanese Office workers to Assess Stress Issues and Sleep problems |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2023/09/23 15:10:50 |
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Basic information
Public title
A survey for Japanese Office workers to Assess Stress Issues and Sleep problems
Acronym
A survey for Japanese Office workers to Assess Stress Issues and Sleep problems (J-OASIS)
Scientific Title
A survey for Japanese Office workers to Assess Stress Issues and Sleep problems
Scientific Title:Acronym
A survey for Japanese Office workers to Assess Stress Issues and Sleep problems (J-OASIS)
Region
| Japan |
Condition
Condition
High-stress workers
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim is to assess the quality of sleep in high-stress workers and to investigate factors associated with the quality.
Basic objectives2
Others
Basic objectives -Others
Fact-finding survey
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sleep architecture based on the analysis of deep sleep (N3) ratio measured by Apple watch.
Key secondary outcomes
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. 20-65 aged regular employees
2. Individuals who can provide written informed consent.
3. Individuals without difficulty in visiting research interviews
4. High-stress workers showing points under 2.14 (national average) in workload domain and 2.53 (national average) in work control domain of the Brief Job Stress Questionnaire.
Key exclusion criteria
1. Workers on leave
2. Workers having night shift (10 pm-5 am)
3. Workers being directly engaged in manufacturing processes/field works, such as manufacturing, construction, restaurant, mining, agriculture, forestry, fishing industry
4. Workers with any psychiatric histories and/or any psychiatric illnesses
5. Workers taking any psychoactive drugs
6. Workers with difficulty in wearing an Apple watch in an appropriate way and over a given time period
7. Workers whom principal investigator/member of this research project consider inappropriate to participate in this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Mimura |
Organization
Keio University, School of Medicine
Division name
Department of Neuropsychiatry
Zip code
106-0016
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3971
mimura@a7.keio.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Sado |
Organization
Keio University, School of Medicine
Division name
Department of Neuropsychiatry
Zip code
106-0016
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3971
Homepage URL
mitsusado@keio.jp
Sponsor or person
Institute
Department of Neuropsychiatry, Keio University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Eisai
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Eisai
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University, School of Medicine, IRB Office
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2021 | Year | 10 | Month | 01 | 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
130
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
| 2021 | Year | 07 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study in high-stress workers.
Main assessments:
-quality of sleep assessed using an Apple watch
-stress level assessed using saliva
-subjective aspects using various questionnaires including sleep and stress.
Management information
Registered date
| 2021 | Year | 09 | Month | 21 | Day |
Last modified on
| 2023 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051837
