UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060373 |
|---|---|
| Receipt number | R000069062 |
| Scientific Title | Research on EEG entrainment and psychological evaluation while listening to 40Hz amplitude-modulated sounds in healthy adults |
| Date of disclosure of the study information | 2026/01/15 |
| Last modified on | 2026/01/15 18:16:02 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study on brain wave synchronization and sound impression while listening to 40Hz amplitude-modulated sounds
Acronym
Research on 40Hz modulated sound
Scientific Title
Research on EEG entrainment and psychological evaluation while listening to 40Hz amplitude-modulated sounds in healthy adults
Scientific Title:Acronym
Research on 40Hz amplitude-modulated sound
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore sound stimuli that can efficiently entrain/evoke 40 Hz brain waves (gamma waves) with low discomfort, and to obtain findings for developing technologies such as dementia prevention.
Basic objectives2
Others
Basic objectives -Others
To explore the EEG synchronization and the impression when listening to modulated sounds.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
40 Hz Phase-Locking Index (PLI)
Key secondary outcomes
40 Hz EEG power, psychological evaluation (discomfort, naturalness), and correlation with hearing levels.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Listening to 40 Hz amplitude-modulated sound stimuli (noise, music, speech, etc.) for approximately 1 hour in total.
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Those who are able to give consent of their own free will, 2) Those who are aged 18 to 59 at the time of obtaining consent.
Key exclusion criteria
1) People with hearing loss, 2) People who are unable to properly undergo EEG measurements and psychological tests, 3) Other people who the principal investigator deems unsuitable.
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, 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, 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 2025-0601
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 | 01 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2026 | 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
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 15 | Day |
Last modified on
| 2026 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069062
