UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060042 |
|---|---|
| Receipt number | R000068515 |
| Scientific Title | Investigation of brain function during speech perception in noise, and changes in brain function associated with auditory rehabilitation |
| Date of disclosure of the study information | 2026/01/22 |
| Last modified on | 2026/01/22 15:25:01 |
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Basic information
Public title
Investigation of brain function during speech perception in noise, and changes in brain function associated with auditory rehabilitation
Acronym
Investigation of brain function during speech perception in noise
Scientific Title
Investigation of brain function during speech perception in noise, and changes in brain function associated with auditory rehabilitation
Scientific Title:Acronym
Investigation of brain function during speech perception in noise
Region
| Japan |
Condition
Condition
Listening Difficulties / Auditory Processing Disorder
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Although previous domestic and international studies have reported on speech understanding at the word or short-phrase level, there have been no studies investigating comprehension of long sentences, as typically encountered in daily life. In the present study, we will examine listening and comprehension, as well as brain function, using sentence-level speech in conditions that approximate real-life listening environments by adding background noise.
Basic objectives2
Others
Basic objectives -Others
There have been no previous investigations into whether auditory rehabilitation induces changes in brain function. This study will therefore evaluate the effects of auditory rehabilitation, including age-related differences, and examine whether brain function changes occur. Through these investigations, we aim to contribute to the development of more effective rehabilitation strategies.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Brain regions showing activation or suppression on magnetoencephalography during sentence listening under noisy conditions will be compared among three groups, young normal hearing adults aged 20 to 40 years, older normal hearing adults aged 65 years or older, and patients with listening difficulties or auditory processing disorder diagnosed in our department. In addition, after implementing our original auditory rehabilitation program, MEG will be performed again under the same conditions to evaluate whether differences in activated or suppressed regions are observed before and after rehabilitation.
Key secondary outcomes
Using the Japanese Hearing in Noise Test (J-HINT), we will evaluate whether speech perception in noise is reduced in the older adult group and the LiD/APD patient group compared with the young adult group, and whether speech perception in noise improves before and after auditory training.
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Participants will perform home-based auditory training involving sentence listening under noisy conditions. The training will be conducted for a maximum of 10 minutes per day over a period of 30 consecutive days. In principle, participants will be instructed to perform the training once daily, for a total of 30 sessions. If a session cannot be performed due to unavoidable circumstances, the missed session will not be made up.
The training stimuli will consist of sentences (comprising several short phrases) presented under multi-talker babble noise. Each training item will be presented twice. During the first presentation, participants will listen to the audio while visually reading the corresponding text displayed in the video. During the second presentation, participants will listen to the audio while reading the same text aloud.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 participants who have provided written informed consent to participate in the study
2 participants who own a device capable of accessing the audio materials such as a smartphone tablet or personal computer or who have access to a device capable of playing CDs
young adults with normal hearing
1 age between 20 and 40 years at the time of consent
2 normal hearing as confirmed by pure tone audiometry four frequency pure tone average pta method B 30 dB or less
3 no subjective symptoms of listening difficulties
older adults with normal hearing
1 age 65 years or older at the time of consent
2 normal hearing as confirmed by pure tone audiometry four frequency pure tone average pta method B 30 dB or less
3 no subjective symptoms of listening difficulties
patients with lid apd
1 age 20 years or older at the time of consent
2 diagnosed with listening difficulties auditory processing disorder lid apd in our department between january 2020 and december 2024 in accordance with the proposed diagnostic criteria described in guidelines for the diagnosis and support of lid apd first edition 2024 amed research outcomes
proposed diagnostic criteria all of the following must be met
1 pure tone audiometry bilateral hearing thresholds less than 25 dB four frequency pta method B
2 speech intelligibility in quiet 85 percent or more
3 presence of subjective listening difficulties defined as
i a score of 109 or less on the questionnaire on listening difficulties developed by Kobuchi et al or
ii a score of 6 or more on the checklist for detection of listening difficulties developed by Ogawa et al
Key exclusion criteria
1 individuals who have contraindications to MRI examination or magnetoencephalography including cochlear implants MRI incompatible cardiac pacemakers or claustrophobia
2 individuals who are pregnant or planning to become pregnant at the time of consent
3 individuals with abnormal findings of the external auditory canal or tympanic membrane
4 individuals who are not suitable for MRI imaging or meg measurement including those who have metal in the body such as cardiac pacemakers prosthetic heart valves cochlear or middle ear implants non titanium cerebral aneurysm clips artificial joints orthopedic fixation bolts magnetic dentures implants orthodontic devices tattoos permanent makeup intrauterine devices or metallic foreign bodies in the eyes, and individuals with claustrophobia
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kishiko |
| Middle name | |
| Last name | Sunami |
Organization
Osaka Metopolitan University
Division name
Otolaryngology
Zip code
545-8585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka-shi, Osaka, Japan
TEL
06-6645-3871
r21575m@omu.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Hashimoto |
Organization
Osaka Metropolitan University
Division name
Otolaryngology
Zip code
545-8585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka-shi, Osaka, Japan
TEL
06-6645-3871
Homepage URL
hsmtksk@omu.ac.jp
Sponsor or person
Institute
Osaka Metropolitan 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
Osaka Metropolitan University
Address
1-4-3 Asahimachi, Abeno-ku, Osaka-shi, Osaka, Japan
Tel
06-6645-3871
gr-med-jibika@omu.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 | 22 | 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
| 2026 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 22 | Day |
Last follow-up date
| 2030 | Year | 12 | 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 | 12 | Month | 10 | Day |
Last modified on
| 2026 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068515
