UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059915 |
|---|---|
| Receipt number | R000068524 |
| Scientific Title | Cognitive Behavioral Changes of Music-Listening Stimulation by Inaudible high-frequency sounds for the Elderly |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/11/28 11:54:13 |
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Basic information
Public title
Cognitive Behavioral Changes of Music-Listening Stimulation by Inaudible high-frequency sounds for the Elderly
Acronym
Cognitive Behavioral Changes of Music-Listening Stimulation by Inaudible high-frequency sounds for the Elderly
Scientific Title
Cognitive Behavioral Changes of Music-Listening Stimulation by Inaudible high-frequency sounds for the Elderly
Scientific Title:Acronym
Cognitive Behavioral Changes of Music-Listening Stimulation by Inaudible high-frequency sounds for the Elderly
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the effects of hypersonic effects on cognitive and mental aspects in the daily life of the elderly.
Basic objectives2
Others
Basic objectives -Others
To compare changes in cognitive function by listening to music containing inaudible high-frequency sounds in the elderly before listening to inaudible sounds and 12 weeks after the start of the study.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in MoCA-J from baseline to the first (12 week) and second (12 week) listening periods.
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Perform inaudible high-frequency sounds listening stimuli
Interventions/Control_2
Perform normal sounds listening stimuli
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
(1)Persons aged 65 years or older at the time of obtaining consent
(2)Persons for whom written consent has been obtained from the principal and the proxy consenting party
Key exclusion criteria
(1)Those who are unable to listen to music and whose general condition is extremely poor or unstable.
(2)Those with obvious impairment of consciousness and difficulty communicating.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Kimura |
Organization
Hamamatsu Photonics K.K.
Division name
Global Strategic Challenge Center Department of Businesss Create Support
Zip code
4348601
Address
5000, Hirakuchi, Hamana-ku, Hamamatsu City, Shizuoka, Japan
TEL
053-586-7111
kimura.yuichi@hpk.co.jp
Public contact
Name of contact person
| 1st name | Toshihiko |
| Middle name | |
| Last name | Mizuno |
Organization
Hamamatsu Photonics K.K.
Division name
Global Strategic Challenge Center Department of Businesss Create Support
Zip code
4348601
Address
5000, Hirakuchi, Hamana-ku, Hamamatsu City, Shizuoka, Japan
TEL
053-586-7111
Homepage URL
toshihiko.mizuno@hpk.co.jp
Sponsor or person
Institute
Hamamatsu Photonics K.K.
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu Photonics K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hamamatsu Medical Photonics Foundation
Address
5000, Hirakuchi, Hamana-ku, Hamamatsu City, Shizuoka, Japan
Tel
053-584-6581
takagi@hmp.or.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 | 12 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 01 | Month | 31 | 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 | 11 | Month | 28 | Day |
Last modified on
| 2025 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068524
