UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016374 |
|---|---|
| Receipt number | R000019016 |
| Scientific Title | The controlled study of medical treatment for the sleep disturbance in the dementia |
| Date of disclosure of the study information | 2015/01/29 |
| Last modified on | 2016/04/04 11:37:23 |
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Basic information
Public title
The controlled study of medical treatment for the sleep disturbance in the dementia
Acronym
The controlled study of medical treatment for the sleep disturbance in the dementia
Scientific Title
The controlled study of medical treatment for the sleep disturbance in the dementia
Scientific Title:Acronym
The controlled study of medical treatment for the sleep disturbance in the dementia
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The controlled study of medical treatment suggested efficacy and safety for sleep disturbance with dementia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
accelerometer
Key secondary outcomes
Neuropsychiatric Inventory
Functional Independence Measure
Mini-Mental State Examination
Biomaker
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
antidepressant
Interventions/Control_2
harbal medicine
Interventions/Control_3
hypnotic
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
dementia
Key exclusion criteria
severe physical illness
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masatake Kurita |
Organization
Sato Hospital, Social medical corporation Koutokukai
Division name
Department of education and research
Zip code
Address
Kunugiduka 948-1, Nanyo City, Yamagata
TEL
+81-238-40-3170
kurita@koutoku.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masatake Kurita |
Organization
Sato Hospital, Social medical corporation Koutokukai
Division name
Department of education and research
Zip code
Address
Kunugiduka 948-1, Nanyo City, Yamagata
TEL
+81-238-40-3170
Homepage URL
kurita@koutoku.or.jp
Sponsor or person
Institute
Social medical corporation Koutokukai
Institute
Department
Personal name
Funding Source
Organization
Sato Hospital
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
Address
Tel
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
| 2015 | Year | 01 | Month | 29 | 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
| 2014 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 01 | Month | 29 | Day |
Date of closure to data entry
| 2025 | Year | 01 | Month | 29 | Day |
Date trial data considered complete
| 2025 | Year | 01 | Month | 29 | Day |
Date analysis concluded
| 2026 | Year | 01 | Month | 29 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 29 | Day |
Last modified on
| 2016 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019016
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
