UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015301 |
|---|---|
| Receipt number | R000017254 |
| Scientific Title | Information therapy using inaudible sounds for behavior and psychological symptoms (BPSD) of dementia |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2016/04/18 13:35:37 |
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Basic information
Public title
Information therapy using inaudible sounds for behavior and psychological symptoms (BPSD) of dementia
Acronym
Information therapy for dementia
Scientific Title
Information therapy using inaudible sounds for behavior and psychological symptoms (BPSD) of dementia
Scientific Title:Acronym
Information therapy for dementia
Region
| Japan |
Condition
Condition
Patients of dementia with behavior and psychological symptoms (BPSD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of information therapy using inaudible sounds for BPSD of dementia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Change from the baseline by the Neuropsychaitric Inventory(NPI) scores after 4-week information therapy
Key secondary outcomes
Change from the baseline by the following items
1. EEG
2. MRI
3. Medication
4. Activities of daily living (ADL)
5. Mini Mental State Examination (MMSE)
Following items in relation to safety
5. Attrition rate of any cause
6. All adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Exposure of inaudible sounds for 4 weeks
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients who meet criteria of major neurocognitive disorders by DSM-5
2. Patients who have one caregiver, who must live with the patient at least ten hours a week and must report the patient's behavior.
Key exclusion criteria
1. In case they show suicide attempt, excitement and violence.
2. In case they have history of developmental disorder, bipolar disorder or alchol/drug abuse.
3. In case they have hearing difficulties.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Honda |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Functional Brain Research, National Institute of Neuroscience
Zip code
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
TEL
042-346-1718
honda@ncnp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Yamashita |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Functional Brain Research, National Institute
Zip code
Address
4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8551, Japan
TEL
042-346-1718
Homepage URL
yamay@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
National Center of Neurology and Psychiatry
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Foundation for advancement of international science
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
| 2014 | Year | 10 | 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
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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 05 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 01 | Day |
Last modified on
| 2016 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017254
