Unique ID issued by UMIN | UMIN000026066 |
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Receipt number | 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 12:05:13 |
Crossover trial of information therapy using inaudible sounds for behavior and psychological symptoms (BPSD) of dementia
Crossover trial of information therapy for dementia
Crossover trial of information therapy using inaudible sounds for behavior and psychological symptoms (BPSD) of dementia
Crossover trial of information therapy for dementia
Japan |
Patients of dementia with behavior and psychological symptoms (BPSD)
Psychiatry |
Others
NO
To evaluate efficacy of information therapy using inaudible sounds for BPSD of dementia
Efficacy
Exploratory
Pragmatic
Phase I,II
Change from the baseline by the Neuropsychaitric Inventory(NPI) scores after 4-week information therapy
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
Interventional
Cross-over
Randomized
Cluster
Single blind -investigator(s) and assessor(s) are blinded
Placebo
2
Treatment
Other |
Exposure of inaudible sounds for 4 weeks
Exposure of audible sounds for 4 weeks
55 | years-old | <= |
95 | years-old | > |
Male and Female
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.
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.
20
1st name | |
Middle name | |
Last name | Manabu Honda |
National Center of Neurology and Psychiatry
Department of Functional Brain Research, National Institute of Neuroscience
4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8502, Japan
042-346-1718
onda@ncnp.go.jp
1st name | |
Middle name | |
Last name | Yuichi Yamashita |
National Center of Neurology and Psychiatry
Department of Functional Brain Research, National Institute of Neuroscience
4-1-1 Ogawa-Higashi, Kodaira, Tokyo 187-8502, Japan
042-346-1718
yamay@ncnp.go.jp
National Center of Neurology and Psychiatry
National Center of Neurology and Psychiatry
Other
NO
2017 | Year | 02 | Month | 09 | Day |
Unpublished
Enrolling by invitation
2017 | Year | 01 | Month | 27 | Day |
2017 | Year | 01 | Month | 27 | Day |
2017 | Year | 02 | Month | 09 | Day |
2018 | Year | 06 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029498
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