UMIN-CTR Clinical Trial

Basic information
Public title	Analysis of factors associated with Crohn's Disease activity and evaluation of the efficacy of improving sleep disturbances on maintenance of remission
Acronym	Association between Crohn's disease activity and sleep status
Scientific Title	Analysis of factors associated with Crohn's Disease activity and evaluation of the efficacy of improving sleep disturbances on maintenance of remission
Scientific Title:Acronym	Association between Crohn's disease activity and sleep status
Region	Japan

Condition
Condition	Crohn's disease
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assess Crohn's disease activity and clarify its relationship to sleep status, stress, and quality of life, with objective indicators. Furthermore, we will provide patient guidance to improve sleep disturbance and investigate whether it is effective in maintaining remission.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Association between disease activity and sleep status in Crohn's disease.
Key secondary outcomes	(1) Relationship between disease activity and stress in Crohn's disease (2) Relationship between disease activity and quality of life in Crohn's disease (3) Changes in sleep status after sleep guidance (4) Changes in disease activity after sleep guidance

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Only one in-person sleep improvement instruction session (approximately 15 minutes).
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 with Crohn's disease aged 18 years or older who are regular visitors to Fukuoka University Hospital
Key exclusion criteria	Patients with the following conditions are excluded: 1. psychiatric disorders, 2. sleep-related diseases such as severe insomnia and sleep apnea syndrome, 3. severe cardiac, liver, or renal diseases, 4. dementia, and 5. scheduled for surgery such as bowel resection or after surgery within 3 months, 6. difficult to answer the questionnaire, 7. otherwise judged as inappropriate by the physician in charge.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Fumihito Middle name Last name Hirai
Organization	Fukuoka University Faculty of Medicine
Division name	Department of Gastroenterology and Medicine
Zip code	8180180
Address	7-45-1, Nanakuma, Jonan-ku, Fukuoka city, Fukuoka
TEL	0928011011
Email	fuhirai@cis.fukuoka-u.ac.jp

Public contact
Name of contact person	1st name Ashizuka Middle name Last name Shinya
Organization	Fukuoka University Faculty of Medicine
Division name	Department of Gastroenterology and Medicine
Zip code	8180180
Address	7-45-1, Nanakuma, Jonan-ku, Fukuoka city, Fukuoka
TEL	0928011011
Homepage URL
Email	ashizuka@fukuoka-u.ac.jp

Sponsor
Institute	Fukuoka University
Institute
Department

Funding Source
Organization	None
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	Fukuoka University Faculty of Medicine
Address	7-45-1, Nanakuma, Jonan-ku, Fukuoka city, Fukuoka
Tel	0928011011
Email	fuhirai@cis.fukuoka-u.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	2022 Year 07 Month 15 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	Preinitiation
Date of protocol fixation	2022 Year 06 Month 28 Day
Date of IRB	2022 Year 07 Month 11 Day
Anticipated trial start date	2022 Year 08 Month 01 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry	2026 Year 06 Month 30 Day
Date trial data considered complete	2026 Year 09 Month 30 Day
Date analysis concluded	2027 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2022 Year 07 Month 12 Day
Last modified on	2022 Year 07 Month 12 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053953