UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058938 |
|---|---|
| Receipt number | R000067404 |
| Scientific Title | Measurement of Auditory Evoked Responses in Children Using gASSR |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/08/30 12:22:37 |
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Basic information
Public title
Measurement of Pediatric Auditory Evoked Responses
Acronym
Pediatric Auditory Evoked Response
Scientific Title
Measurement of Auditory Evoked Responses in Children Using gASSR
Scientific Title:Acronym
gASSR for Children
Region
| Japan |
Condition
Condition
hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In previous studies, we measured gap-evoked auditory steady-state responses (gASSR) induced by embedding 40 and 80 Hz silent gaps within broadband noise to objectively assess auditory temporal resolution in adults . Conducting tests requiring subject response in children is difficult in routine clinical practice. We hypothesize that the ASSR could be used to objectively assess auditory function in children, and we measure brain activity using electroencephalography (EEG).
Basic objectives2
Others
Basic objectives -Others
Nothing in particular
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Auditory Evoked Response
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 1 | months-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children with normal hearing
Key exclusion criteria
History of mental or neurological disorders, cardiac pacemaker, neurostimulator, prior head surgery, pregnancy, wearing orthodontic appliances (dental fillings and crowns are acceptable)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hidehiko |
| Middle name | |
| Last name | Okamoto |
Organization
International University of Health and Welfare
Division name
School of Medicine, Department of Medical Sciences
Zip code
286-0048
Address
4-3 Kozunomori, Narita City, Chiba Prefecture
TEL
0476-20-7701
okamoto@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Hidehiko |
| Middle name | |
| Last name | Okamoto |
Organization
International University of Health and Welfare
Division name
School of Medicine, Department of Medical Sciences
Zip code
286-0048
Address
4-3 Kozunomori, Narita City, Chiba Prefecture
TEL
0476-20-7701
Homepage URL
okamoto@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
4-3 Kozunomori, Narita City, Chiba Prefecture
Tel
0476-20-7701
okamoto@iuhw.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 | 10 | 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 | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 30 | 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
Nothing in particular
Management information
Registered date
| 2025 | Year | 08 | Month | 30 | Day |
Last modified on
| 2025 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067404
