UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038055 |
|---|---|
| Receipt number | R000043376 |
| Scientific Title | Exploratory research about associations between psychophysiological pathology and therapeutic response in adult insomnia |
| Date of disclosure of the study information | 2019/09/19 |
| Last modified on | 2024/03/23 09:20:11 |
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Basic information
Public title
Exploratory research about associations between pathology and therapeutic response in adult insomnia
Acronym
Pathology and therapeutic responses in insomnia
Scientific Title
Exploratory research about associations between psychophysiological pathology and therapeutic response in adult insomnia
Scientific Title:Acronym
Associations between psychophysiological pathology and therapeutic response in insomnia
Region
| Japan |
Condition
Condition
Insomnia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Ton explore the relationship between psychophysiological pathology and therapeutic responses in insomniacs
Basic objectives2
Others
Basic objectives -Others
Availability for diagnosis or predictive factor
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MRI measurements in brain structure
Key secondary outcomes
clinical information in medical chart
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients in our sleep clinic
Key exclusion criteria
unspecified
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Kuriyama |
Organization
National Center of Neurology & Psychiatry
Division name
Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code
187-8553
Address
4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL
042-346-2071
kenichik@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Kuriyama |
Organization
National Center of Neurology & Psychiatry
Division name
Department of Sleep-Wake Disorders, National Institute of Mental Health
Zip code
187-8553
Address
4-1-1, Ogawa-Higashi, Kodaira, Tokyo
TEL
042-346-2071
Homepage URL
kenichik@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology & Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
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
Ethical Review Board of National Center of Neurology & Psychiatry
Address
4-1-1, Ogawa-Higashi, Kodaira, Tokyo
Tel
042-341-2711
rinri-jimu@ncnp.go.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
国立精神・神経医療研究センター病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
23
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
Terminated
Date of protocol fixation
| 2019 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exhaustively exploring the association between markers in brain structure measured by MRI and psychophysiological findings, treatment processes and responses.
Management information
Registered date
| 2019 | Year | 09 | Month | 19 | Day |
Last modified on
| 2024 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043376
