UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054929 |
|---|---|
| Receipt number | R000062709 |
| Scientific Title | Investigation of the components of insomnia through interviews |
| Date of disclosure of the study information | 2024/07/10 |
| Last modified on | 2024/07/10 18:45:36 |
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Basic information
Public title
Investigation of the components of insomnia through interviews
Acronym
Investigation of the components of insomnia through interviews
Scientific Title
Investigation of the components of insomnia through interviews
Scientific Title:Acronym
Investigation of the components of insomnia through interviews
Region
| Japan |
Condition
Condition
Normal subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the insomnia psychological and enviromental component factors in addition to the physical factors.
Basic objectives2
Others
Basic objectives -Others
Medical anthropology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Most common insomnia components identified using the Design, Implementation, Monitoring and Evaluation (DIME) module.
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
| 75 | years-old | > |
Gender
Female
Key inclusion criteria
1) History of primary insomnia
2) Allows interviews with roommates
3) No history of severe CNS disease
4) No history of psychiatric disorder other than primary insomnia
5) Japanese as a mother tongue
Key exclusion criteria
1) A person who continuing their treatment for insomnia at the time of the examination.
2) Not allows interviews with roommates
3) History of severe CNS disease
4) History of psychiatric disorder other than primary insomnia
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Eiji |
| Middle name | |
| Last name | Shimizu |
Organization
Graduate School of Medicine and School of Medicine
Division name
Department of Cognitive Behavioral Physiology
Zip code
2608670
Address
Inohana 1-8-1, Chuou Ward, Chiba city, Chiba, Japan
TEL
043-226-2027
eiji@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Yasuka |
| Middle name | |
| Last name | SaSahara |
Organization
Graduate School of Medicine and School of Medicine, Chiba University
Division name
Department of Cognitive Behavioral Physiology
Zip code
2608670
Address
Inohana 1-8-1, Chuou Ward, Chiba city, Chiba, Japan
TEL
08031254534
Homepage URL
y.sahara@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee of Chiba University
Address
1-8-1Inohaba, Chuo-ku, Chiba, Chiba
Tel
043-251-1111
inohana-rinri@chiba-u.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
| 2024 | Year | 07 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational test
Conduct 3-5 interviews with subjects with a history of insomnia and interviews with their cohabitants.
Management information
Registered date
| 2024 | Year | 07 | Month | 10 | Day |
Last modified on
| 2024 | Year | 07 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062709
