UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060997 |
|---|---|
| Receipt number | R000069778 |
| Scientific Title | Development of a Relaxation-Based Approach for Enhancing Auditory Neurofeedback Training: A Single-Blind Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/03/20 |
| Last modified on | 2026/03/20 04:36:56 |
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Basic information
Public title
Development of a Relaxation and Music Based Neurofeedback Training Approach
Acronym
Developing a Relaxation-Based Neurofeedback Method Using Music
Scientific Title
Development of a Relaxation-Based Approach for Enhancing Auditory Neurofeedback Training: A Single-Blind Randomized Controlled Trial
Scientific Title:Acronym
Relaxation-based Enhancement of Auditory Neurofeedback Training: Single-Blind RCT
Region
| Japan |
Condition
Condition
Healthy Individuals
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study investigates the effects of pre-training-induced alpha-band activity on subsequent increases and enhancements, as well as the duration of these effects, to develop effective techniques for auditory neurofeedback facilitation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Differences in the magnitude of changes in alpha-wave fluctuations before, during, and after the 4-week intervention.
Key secondary outcomes
The following items at prior to the start of the intervention
(1).Differences in Adolescent/Adult Sensory Profile(A/ASP)scores
(2).Differences in Diagnostic Inventory of Health and life Habit(DIHAL.2)scores
(3).Differences in daily physical activity habits and sleep status as measured using the wGT3X-BT sensor.
The following items before, during, and after the 4-week intervention
(1).Differences in autonomic nervous system response patterns among participants based on PPG acquired using MUSE.
(2).Differences in Digit Span test scores
(3).Differences in N-Back Test scores
(4).Differences in Test of Variables of Attention(TOVA)scores
(5).Differences in Rey-Osterrieth Complex Figure Test(ROCF)scores
(6).Differences in Standard verbal paired-associate learning test(S-PA)scores
(7).Differences in Profile of mood states 2nd Edition(POMS2)scores
(8).Differences in Liebowitz Social Anxiety Scale -Japanese version(LSAS-J)scores
(9).Differences in Japanese version of the Courage Measure scores
(10).Differences in Multidimensional Assessment of Interoceptive Awareness(MAIA)scores
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Pre-Training and Auditory Neurofeedback Training Intervention
A quiet room in the Human Health Sciences Building will be prepared. One research participant and one researcher will be present in the room. The room will be equipped with an electroencephalography (EEG) device (MUSE), one computer for music playback and data collection, and an iPad for playing instructional videos for the pre-training session. In this quiet environment, the participant will sit in a chair and undergo the pre-training with their eyes closed while following the audio instructions provided in the instructional video. Subsequently, while maintaining the eyes-closed state, the participant will listen to the classical music piece Air on the G String and will be instructed to direct their attention toward perceiving the sound of a babbling stream embedded in the musical background as clearly and for as long as possible. The total duration of each intervention session will be 30 minutes.
Interventions/Control_2
Auditory Neurofeedback Training Intervention
A quiet room in the Human Health Sciences Building will be prepared. One research participant and one researcher will enter the room. The room will be equipped with an electroencephalography (EEG) device (MUSE) and one computer for music playback and data collection. In this quiet environment, the participant will sit in a chair and, with their eyes closed, listen to the classical music piece Air on the G String. The participant will be instructed to direct their attention toward perceiving the sound of a babbling stream embedded in the musical background as clearly and for as long as possible. The total duration of each intervention session will be 30 minutes.
Interventions/Control_3
Music Intervention
A quiet room in the Human Health Sciences Building will be prepared. One participant and one researcher will enter the room. The room will be equipped with an electroencephalography (EEG) device (MUSE) and a computer for music playback and data collection. In this quiet environment, the participant will be seated in a chair and instructed to listen to the classical music piece Air on the G String with their eyes closed. Each intervention session will last 30 minutes.
Interventions/Control_4
Control Group
A quiet room in the Human Health Sciences Building will be prepared. One research participant and one researcher will enter the room. The room will be equipped with an electroencephalography (EEG) device (MUSE) and one computer for data collection. In this quiet environment, the participant will sit in a chair and maintain a relaxed state with their eyes closed, without listening to the classical music piece Air on the G String. The duration of each intervention session will be 30 minutes.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Students and working adults residing in Kyoto Prefecture.
Normal hearing confirmed for all participants using the Mimi Hearing Test administered on an iPad.
Key exclusion criteria
Prior experience with neurofeedback.
A history of Central and Peripheral Nervous System-related medication use, neurological disorders, psychiatric disorders, respiratory diseases, or cardiovascular diseases.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Inadomi |
Organization
Graduate School of Kyoto University
Division name
Brain Function and Rehabilitation, Department of Advanced Occupational Therapy,Human Health Sciences, Graduate School of Medicine
Zip code
606-8507
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3943
inadomi.hiroyuki.5e@kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Inadomi |
Organization
Graduate School of Kyoto University
Division name
Brain Function Rehabilitation, Department of Human Health Sciences, Graduate School of Medicine
Zip code
606-8507
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
TEL
075-751-3943
Homepage URL
inadomi.hiroyuki.5e@kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
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
Medical Ethics Committee, Graduate School of Medicine, Faculty of Medicine and University Hospital, Kyoto University
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto 606-8501, Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
京都大学大学院医学研究科人間健康科学系専攻(京都府)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 20 | 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 | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | 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
| 2026 | Year | 03 | Month | 20 | Day |
Last modified on
| 2026 | Year | 03 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069778
