UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050503 |
|---|---|
| Receipt number | R000057526 |
| Scientific Title | Intervention Study on Time in Bed in Nursing Home Residents with Dementia |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/05/17 09:51:26 |
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Basic information
Public title
Intervention Study on Time in Bed in Nursing Home Residents with Dementia
Acronym
Intervention Study on Time in Bed in Nursing Home Residents with Dementia
Scientific Title
Intervention Study on Time in Bed in Nursing Home Residents with Dementia
Scientific Title:Acronym
Intervention Study on Time in Bed in Nursing Home Residents with Dementia
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine changes in clinical scores as a result of appropriate time bed
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
METs
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Sleep restriction therapy to optimize sleep efficiency
Interventions/Control_2
Continuation of standard care
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Dementia (DSM-5) patients newly admitted to nursing home
Key exclusion criteria
Presence of significant physical disorders
Comorbidity of neurodevelopmental disorder group, schizophrenia spectrum disorder group, bipolar disorder group, depressive disorder group, anxiety disorder group, obsessive-compulsive disorder group, dissociative disorder group, somatic symptom disorder group, eating behavior disorder group, substance-related disorder group
Comorbid SAS with RDI > 15
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Arai |
Organization
Kurita Hospital
Division name
department of psychiatry
Zip code
380-0823
Address
695 Kurita, Nagano City
TEL
026-226-1311
soundofdistiny@icloud.com
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Arai |
Organization
Kurita Hospital
Division name
department of psychiatry
Zip code
380-0823
Address
695 Kurita, Nagano City
TEL
026-226-1311
Homepage URL
soundofdistiny@icloud.com
Sponsor or person
Institute
Kurita Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurita Hospital
Address
695 Kurita, Nagano City
Tel
026-226-1311
aoundofdistiny@icloud.com
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
| 2023 | Year | 04 | Month | 01 | 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
0
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
| 2023 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 03 | Month | 06 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057526
| Research Plan | |
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| 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 |
