UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058435 |
|---|---|
| Receipt number | R000066815 |
| Scientific Title | An Exploratory Clinical Study Toward the Development of a Non-Pharmacological Treatment Using Inaudible High-Frequency Sound for Behavioral and Psychological Symptoms of Dementia (BPSD) |
| Date of disclosure of the study information | 2025/07/11 |
| Last modified on | 2025/07/11 17:03:08 |
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Basic information
Public title
An Exploratory Clinical Study Toward the Development of a Non-Pharmacological Treatment Using Inaudible High-Frequency Sound for Behavioral and Psychological Symptoms of Dementia (BPSD)
Acronym
BPSD-HFS Study
Scientific Title
An Exploratory Clinical Study Toward the Development of a Non-Pharmacological Treatment Using Inaudible High-Frequency Sound for Behavioral and Psychological Symptoms of Dementia (BPSD)
Scientific Title:Acronym
BPSD-HFS Study
Region
| Japan |
Condition
Condition
Dementia
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will present natural environmental sounds rich in high-frequency components as background music in group homes where patients with behavioral and psychological symptoms of dementia (BPSD) reside. As a control condition, placebo sounds will be used, consisting of the same natural environmental sounds with the high-frequency components removed. A crossover comparative trial will be conducted to evaluate the effectiveness of the high-frequency components.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NPI-NH
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Acoustic information containing inaudible high-frequency components
Interventions/Control_2
Acoustic information with inaudible high-frequency components removed from the same sound source
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
| 55 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Meets the diagnostic criteria for dementia according to the DSM-5 (regardless of etiological subtype)
2. Male or female individuals aged 55 years or older and under 100 years
3. Has a caregiver who can report on the patient's daily life
4. Has a score of 6 or higher on the BPSD assessment scale NPI-Q (a questionnaire administered to the caregiver)
Key exclusion criteria
1. Has a diagnosis of bipolar disorder, schizophrenia, or developmental disorder
2. Does not have a legal guardian or representative who can provide consent for participation in the study
3. Deemed inappropriate for participation by the attending physician or principal investigator
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Honda |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Information Medicine, National Institute of Neuroscience
Zip code
187-8502
Address
4-1-1 Ogawa-higashi, Kodaira, Tokyo
TEL
042-346-1718
honda@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Honda |
Organization
National Center of Neurology and Psychiatry
Division name
Department of Information Medicine, National Institute of Neuroscience
Zip code
187-8502
Address
4-1-1 Ogawa-higashi, Kodaira, Tokyo
TEL
0423461718
Homepage URL
honda@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry
Address
4-1-1 Ogawa-higashi, Kodaira, Tokyo
Tel
042-341-2711
rinri-jimu@ncnp.go.jp
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
| 2025 | Year | 07 | Month | 11 | 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
17
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 11 | Day |
Last modified on
| 2025 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066815
