UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060285 |
|---|---|
| Receipt number | R000067606 |
| Scientific Title | Development of an auditory task for the early detection of mild cognitive impairment: a preliminary study on sensitivity to modulated sounds in young healthy adults |
| Date of disclosure of the study information | 2026/01/08 |
| Last modified on | 2026/01/07 16:04:09 |
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Basic information
Public title
Development of an auditory task for the early detection of mild cognitive impairment: a preliminary study on sensitivity to sounds in young healthy adults
Acronym
A preliminary study on an auditory task for the early detection of mild cognitive impairment
Scientific Title
Development of an auditory task for the early detection of mild cognitive impairment: a preliminary study on sensitivity to modulated sounds in young healthy adults
Scientific Title:Acronym
A preliminary study on an auditory task for the early detection of mild cognitive impairment
Region
| Japan |
Condition
Condition
Young healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate differences in auditory sensitivity across modulation conditions in young healthy adults and to identify suitable stimulus parameters for future studies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The minimum sound pressure level required to detect a modulated sound
Key secondary outcomes
The minimum modulation depth required to detect a modulated sound, the suitable increments for examining them
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
An auditory judgment task is conducted for approximately 30 minutes.
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
| 35 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Men and women aged 18 to 35 who provide written informed consent in Japanese
Key exclusion criteria
1. Individuals with hearing impairments
2. Individuals with uncorrectable visual impairments
3. Individuals with a history of neuropsychiatric disorders (e.g., dementia, mild cognitive impairment, epilepsy, developmental disorders, depression, schizophrenia)
4. Individuals with a history of psychotropic medication use (e.g., mood stabilizers, antipsychotics)
5. Individuals with alcohol or drug dependence
6. Individuals with a history of cerebrovascular disease (e.g., cerebral hemorrhage, cerebral infarction)
7. Individuals with a history of concussion or severe head injury
8. Individuals with a first-degree relative (parent, sibling, or child) with a history of neuropsychiatric disorders
9. Individuals with a history of heart disease or other conditions that may cause sudden changes in physical health
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yubin |
| Middle name | |
| Last name | Sung |
Organization
Kyushu University
Division name
Department of Health Sciences, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6959
sung.yubin.417@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yubin |
| Middle name | |
| Last name | Sung |
Organization
Kyushu University
Division name
Department of Health Sciences, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-6959
Homepage URL
sung.yubin.417@m.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu 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
Ethics Committees of Kyushu University Hospital and Medical Institutions
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel
092-642-5082
byskenkyu@jimu.kyushu-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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 08 | 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 | 12 | Month | 25 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 08 | 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 | 01 | Month | 07 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000067606
