UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059054 |
|---|---|
| Receipt number | R000067550 |
| Scientific Title | Exploratory Evaluation of Auditory Attention Based on EEG and Physiological Indicators during Acoustic Stimulation |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/09/11 10:30:15 |
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Basic information
Public title
Study on the Evaluation of Auditory Attention Using EEG during Acoustic Stimulation
Acronym
EEG-Auditory Attention Study
Scientific Title
Exploratory Evaluation of Auditory Attention Based on EEG and Physiological Indicators during Acoustic Stimulation
Scientific Title:Acronym
EEG-Auditory Attention Evaluation
Region
| Japan |
Condition
Condition
Auditory attention deficit or decline in attentional function
Classification by specialty
| Psychiatry | Oto-rhino-laryngology | Rehabilitation medicine |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to explore evaluation indices of auditory attention in humans through simultaneous measurement of EEG activity and physiological indicators during acoustic stimulation. Particular focus is placed on individual differences in attentional responses to auditory stimuli, examining how these vary according to age and hearing function. Using non-invasive EEG devices, we aim to record and analyze neurophysiological responses to attention-capturing sound stimuli in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in the amplitude and latency of event-related potentials (ERPs), particularly P300 and stimulus preceding negativity (SPN), in response to auditory stimulation. These neurophysiological measures will be used to quantitatively assess attentional responses to auditory stimuli.
Key secondary outcomes
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
EEG responses will be recorded using EEG systems (NVX 24 or Neuro DCcap21) while auditory stimuli are presented.
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
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults aged 20 to 79 years who understand Japanese. Participants who have received a full written explanation of the study and provided informed consent. No history of severe auditory or attentional disorders.
Key exclusion criteria
Individuals with a history of neurological or psychiatric disorders. Individuals with severe hearing loss or those using hearing aids/cochlear implants. Individuals with skin conditions or allergies in electrode attachment areas. Others deemed ineligible by the principal investigator.
Target sample size
340
Research contact person
Name of lead principal investigator
| 1st name | Naoya |
| Middle name | |
| Last name | Obama |
Organization
Kawasaki Medical University Hospital
Division name
Rehabilitation Center
Zip code
701-0192
Address
577 Matsushima, Kurashiki City, Okayama Prefecture
TEL
086-462-1111
obama@mw.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Naoya |
| Middle name | |
| Last name | Obama |
Organization
Kawasaki Medical University Hospital
Division name
Rehabilitation Center
Zip code
701-0192
Address
577 Matsushima, Kurashiki City, Okayama Prefecture
TEL
086-462-1111
Homepage URL
obama@mw.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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
Kawasaki Medical University
Address
577 Matsushima, Kurashiki City, Okayama Prefecture
Tel
086-462-1111
kmsrec@med.kawasaki-m.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 11 | 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 | 10 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2029 | 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
| 2025 | Year | 09 | Month | 11 | Day |
Last modified on
| 2025 | Year | 09 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067550
