UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048357 |
|---|---|
| Receipt number | R000053953 |
| Scientific Title | Analysis of factors associated with Crohn's Disease activity and evaluation of the efficacy of improving sleep disturbances on maintenance of remission |
| Date of disclosure of the study information | 2022/07/15 |
| Last modified on | 2022/07/12 17:23:04 |
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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
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
ashizuka@fukuoka-u.ac.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053953
