UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053573 |
|---|---|
| Receipt number | R000061133 |
| Scientific Title | Research on directional listening ability |
| Date of disclosure of the study information | 2024/02/08 |
| Last modified on | 2024/02/08 16:42:06 |
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Basic information
Public title
Research on directional listening ability
Acronym
Research on directional listening ability
Scientific Title
Research on directional listening ability
Scientific Title:Acronym
Research on directional listening ability
Region
| Japan |
Condition
Condition
Hearing loss
Cochlear implant users
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In conversational listening, signals from the inner ear from the left and right ear are rapidly processed in the auditory nerve circuit to extract and understand the necessary directional information and conversation information from coexisting environmental sounds (noise), and memory and cognitive functions such as attention to conversation information and retention of a series of information also play an important role. The directional sense of sound processed by the central auditory system is based on the separation and synthesis of signals from the left and right hemispheres, and plays an important role in daily life. The cocktail party effect The directional sense is also useful in the diagnosis of posterior labyrinthine disorder (a central disorder), because the difference in time and intensity between the two ears is produced by the direction of the sound source, with the difference in time playing an important role at low frequencies and the difference in intensity at high frequencies becoming clearer due to the shading effect of the cranium.
The phenomenon of an increase in the auditory range value (decrease in hearing acuity) with age, especially at high frequencies, is well known as senile hearing loss. In addition to this, elderly people characteristically complain of a strong decrease in their ability to hear speech, such as "I can hear sounds but cannot understand what is being said" or "I cannot hear in noisy environments. In addition to an elevated auditory threshold due to peripheral auditory dysfunction, central auditory processing may be impaired. This is thought to make it more difficult to retain and comprehend information. In recent years, the use of cochlear implants for hearing loss has progressed, and it is now possible to improve hearing in patients with severe hearing loss, whereas previously it was impossible to intervene.
Basic objectives2
Others
Basic objectives -Others
In this study, with the aim of evaluating the central circuits that process directional perception in particular, we developed a left-right, single-syllable listening test in noise, a long-sentence listening test, event-related potentials to measure auditory perception in the center, and DPOAE (DPOAE in the high frequency domain), a method to evaluate detailed inner ear function other sensory evaluation.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
In addition to analyzing normal values by age for each newly developed test, correlations between tests, etc. will also be analyzed. Since this is not a clinical trial to demonstrate the efficacy of therapeutic actions, there will be no primary endpoint.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) One of the following applies
a) Hearing impaired (hearing level less than 25dB)
b) Hearing impaired (hearing level of 25 dB or more)
c) Cochlear implant users
2) 20 years of age or older
3) Those who have given consent to participate in the research
Key exclusion criteria
Persons who have submitted a refusal to participate in the research
Those who are unable to undergo testing due to otitis externa, otitis media, pathological cognitive impairment, or other diseases
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Kondo |
Organization
The University of Tokyo Hospital
Division name
Department of Otolaryngology and Head and Neck Surgery
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku
TEL
03-3815-5411
tkamogashira-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Teru |
| Middle name | |
| Last name | Kamogashira |
Organization
The University of Tokyo Hospital
Division name
Department of Otolaryngology and Head and Neck Surgery
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku
TEL
03-3815-5411
Homepage URL
tkamogashira-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
The University of Tokyo Hospital
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
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2024 | Year | 02 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 08 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 02 | Month | 08 | Day |
Last modified on
| 2024 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061133
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| Registered date | File name |
| Research case data | |
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