UMIN-CTR Clinical Trial

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
Email	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
Email	ynaito@koto.kpu-m.ac.jp

Sponsor
Institute	Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016136