UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056820 |
|---|---|
| Receipt number | R000064748 |
| Scientific Title | A survey study of the current situation and health risks of shift workers; a case-control study |
| Date of disclosure of the study information | 2025/01/26 |
| Last modified on | 2025/05/18 15:19:58 |
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Basic information
Public title
Survey research on the current situation and health risks of shift workers
Acronym
Survey research on the current situation and health risks of shift workers
Scientific Title
A survey study of the current situation and health risks of shift workers; a case-control study
Scientific Title:Acronym
A survey study of the current situation and health risks of shift workers; a case-control study
Region
| Japan |
Condition
Condition
Sleep apnea and other sleep disorders
Classification by specialty
| Cardiology | Pneumology | Psychosomatic Internal Medicine |
| Psychiatry | Oto-rhino-laryngology | Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To gather information on the current situation of shift workers and its impact on their health and wellbeing, and to propose health measures
Basic objectives2
Others
Basic objectives -Others
Proposed health measures for shift workers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Associations of Shift Work with Disease Risk, Health Effects, Work Efficiency, and Accidents.
Relevance of Shift Work to Disability Factors in the Treatment of Sleep Disorders.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients treated for sleep disorders such as sleep apnea syndrome at each medical institution in the collaborative research group
Key exclusion criteria
Patients who offered psychological burden when explaining the questionnaire
Patients under 18 years of age
Target sample size
6450
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Wada |
Organization
Kokushikan University
Division name
department of science and engineering
Zip code
206-8515
Address
7-3-1 Nagayama, Tama City, Tokyo
TEL
042-339-7200
twada@kokushikan.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Higami |
Organization
Higami ENT & Snore Sleep Clinic
Division name
otorhinolaryngology
Zip code
689-3553
Address
1584-3 Hiezu,Hiezu Village, Saihaku-gun, Tottori, Japan
TEL
0859-21-3387
Homepage URL
higami-ent@chic.ocn.ne.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kokushikan University Ethics Committee
Address
4-28-1 Setagaya, Setagaya-ku, Tokyo
Tel
03-5481-3306
kenkyu@kokushikan.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
| 2025 | Year | 01 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Questionnaire survey
Management information
Registered date
| 2025 | Year | 01 | Month | 26 | Day |
Last modified on
| 2025 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064748
