UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062313 |
|---|---|
| Receipt number | R000071309 |
| Scientific Title | Study on the Effects of Listening to 40 Hz Amplitude-Modulated Sounds for Six Months on Gamma-Band EEG in Healthy Older Adults |
| Date of disclosure of the study information | 2026/07/24 |
| Last modified on | 2026/07/23 12:06:59 |
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Basic information
Public title
Study on the Effects of Listening to 40Hz Amplitude-Modulated Sounds on Gamma-Band Brain Wave
Acronym
Research on 40Hz modulated sound
Scientific Title
Study on the Effects of Listening to 40 Hz Amplitude-Modulated Sounds for Six Months on Gamma-Band EEG in Healthy Older Adults
Scientific Title:Acronym
Research on 40Hz modulated sound
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effects of long-term listening to 40 Hz modulated sounds on gamma-band EEG activity in healthy older adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in gamma-band EEG power during performance of the auditory oddball paradigm before and after a six-month intervention.
Key secondary outcomes
40 Hz ASSR, hearing level, MMSE, GDS, cognitive function assessment test (RBANS, FNAT), resting-state EEG, additional scores (sleep, apathy, POMS, STAI)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Listening to music stimuli subjected to 40 Hz amplitude modulation (1 hour daily for a total of 180 days).
Interventions/Control_2
Listening to music stimuli subjected to noise-addition processing (1 hour daily for a total of 180 days).
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Individuals capable of providing written informed consent to participate in the study of their own free will
(2) Individuals aged 65 to 74 years at the time of obtaining consent
(3) Gender: No restriction
Key exclusion criteria
(1) Individuals with hearing impairment
(2) Individuals with depression or anxiety disorders (diagnosed with depression/anxiety disorders or currently taking antidepressants/anxiolytics) or those with a GDS-15 score of 5 or higher
(3) Individuals with dementia (diagnosed with dementia or currently taking dementia medication) or those with an MMSE score of 27 or lower
(4) Individuals diagnosed with epilepsy or currently taking medication for epilepsy
(5) Individuals who self-report having a mental disorder such as schizophrenia spectrum disorder or bipolar disorder
(6) Individuals who self-report having a developmental disorder such as autism spectrum disorder or attention-deficit/hyperactivity disorder (ADHD)
(7) Individuals unable to properly undergo EEG measurement and psychological testing
(8) Individuals with a history of routine use of commercially available products that play 40 Hz modulated sounds
(9) Any other individuals deemed unsuitable by the principal investigator or co-investigators
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Soeta |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Molecular Biosystems Research Institute, Life Science and Biotechnology
Zip code
563-8577
Address
1-8-31 Midorigaoka, Ikeda, Osaka 563-8577, Japan
TEL
+81-50-3522-7155
y.soeta@aist.go.jp
Public contact
Name of contact person
| 1st name | Yoshiharu |
| Middle name | |
| Last name | Soeta |
Organization
National Institute of Advanced Industrial Science and Technology (AIST)
Division name
Molecular Biosystems Research Institute, Life Science and Biotechnology
Zip code
563-8577
Address
1-8-31 Midorigaoka, Ikeda, Osaka 563-8577, Japan
TEL
+81-50-3522-7155
Homepage URL
y.soeta@aist.go.jp
Sponsor or person
Institute
National Institute of Advanced Industrial Science and Technology (AIST)
Institute
Department
Personal name
Funding Source
Organization
Pixie Dust Technologies, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Pixie Dust Technologies, Inc.
Name of secondary funder(s)
Shionogi & Co., Ltd.
IRB Contact (For public release)
Organization
National Institute of Advanced Industrial Science and Technology (AIST) Environment and Safety Division Life Science Experiment Management
Address
1-1-1 Higashi, Tsukuba, Ibaraki 305-8561 Japan
Tel
+81-29-861-2120
safe-life-ml@aist.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
Life 2025-0619
Org. issuing International ID_1
National Institute of Advanced Industrial Science and Technology (AIST) Environment and Safety Division Life Science Experiment Management
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
国立研究開発法人 産業技術総合研究所（大阪府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 24 | 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
| 2026 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2026 | Year | 07 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 07 | Month | 23 | Day |
Last modified on
| 2026 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071309
