UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013889 |
|---|---|
| Receipt number | R000016136 |
| Scientific Title | Fact-finding of sleep disorder in the inflammatory bowel disease patient |
| Date of disclosure of the study information | 2014/05/10 |
| Last modified on | 2021/11/10 23:51:31 |
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Basic information
Public title
Fact-finding of sleep disorder in the inflammatory bowel disease patient
Acronym
Sleep disorder and inflammatory bowel disease
Scientific Title
Fact-finding of sleep disorder in the inflammatory bowel disease patient
Scientific Title:Acronym
Sleep disorder and inflammatory bowel disease
Region
| Japan |
Condition
Condition
inflammatory bowel disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To make the correlation clear between the condition of IBD and sleep disorder to validate the relation between IBD condition of a patient and sleep disorder, the ratio of shift worker, the change working form.
Basic objectives2
Others
Basic objectives -Others
Observational study based on the questionnaire
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To perform the investigation in the question vote entry about having sleep disorder and shift working or not, and examine the relation to clinical course, and disease severity of IBD.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
In this study, we enrolled IBD patients who visiting hospital for medication. The hospital of Kyoto prefectural university of medicine and its related institutions are included for this study.
Key exclusion criteria
The patients who did not agree with this study.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterolgy and Hepatology
Zip code
602-8566
Address
465 Kajiicho Hirokoji, Kawaramachidori, Kamigyo-ku, Kyoto
TEL
075-251-5519
ynaito@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | Yuji |
| Middle name | |
| Last name | Naito |
Organization
Kyoto Prefectural University of Medicine
Division name
Molecular Gastroenterology and Hepatology
Zip code
602-8566
Address
465 Kajii-cho, Hirokoji, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5519
Homepage URL
ynaito@koto.kpu-m.ac.jp
Sponsor or person
Institute
Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Ethics Review Committee, Kyoto Prefectural Universit of Medicine
Address
465 Kajiicho Kawaramachidori Kamigyo-ku, Kyoto
Tel
+81-75-251-5337
rinri@koto.kpu-m.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
| 2014 | Year | 05 | Month | 10 | 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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2014 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
About having sleep disorder and shift working or not, we will perform the investigation in the question vote entry form and plan the examination of clinical course, connection with the disease severity. The question vote prepares Pittsburgh sleep question (the question about the sleep disorder for latest one month) vote and the item (shift working, and duty forms) which I made originally.
Management information
Registered date
| 2014 | Year | 05 | Month | 06 | Day |
Last modified on
| 2021 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016136
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
