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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000026066 |
Receipt No. | R000029498 |
Scientific Title | Crossover trial of information therapy using inaudible sounds for behavior and psychological symptoms (BPSD) of dementia |
Date of disclosure of the study information | 2017/02/09 |
Last modified on | 2018/06/27 |
Basic information | ||
Public title | Crossover trial of information therapy using inaudible sounds for behavior and psychological symptoms (BPSD) of dementia | |
Acronym | Crossover trial of information therapy for dementia | |
Scientific Title | Crossover trial of information therapy using inaudible sounds for behavior and psychological symptoms (BPSD) of dementia | |
Scientific Title:Acronym | Crossover trial of information therapy for dementia | |
Region |
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Condition | ||
Condition | Patients of dementia with behavior and psychological symptoms (BPSD) | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate efficacy of information therapy using inaudible sounds for BPSD of dementia |
Basic objectives2 | 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 6. Attrition rate of any cause 7. All adverse events |
Base | |
Study type | Interventional |
Study design | |
Basic design | Cross-over |
Randomization | Randomized |
Randomization unit | Cluster |
Blinding | Single blind -investigator(s) and assessor(s) are blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | Exposure of inaudible sounds for 4 weeks | |
Interventions/Control_2 | Exposure of audible sounds for 4 weeks | |
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 |
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Age-upper limit |
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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. |
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Key exclusion criteria | 1. In case they show suicide attempt, excitement and violence.
2. In case they have history of developmental disorder, bipolar disorder. 3. In case they have hearing difficulties. |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 187-8502, Japan | ||||||
TEL | 042-346-1718 | ||||||
onda@ncnp.go.jp |
Public contact | |||||||
Name of contact person |
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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 187-8502, Japan | ||||||
TEL | 042-346-1718 | ||||||
Homepage URL | |||||||
yamay@ncnp.go.jp |
Sponsor | |
Institute | National Center of Neurology and Psychiatry |
Institute | |
Department |
Funding Source | |
Organization | National Center of Neurology and Psychiatry |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
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IRB Contact (For public release) | |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
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Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Enrolling by invitation | ||||||
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Management information | |||||||
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029498 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |