UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052354 |
|---|---|
| Receipt number | R000059488 |
| Scientific Title | Assessment of auditory temporal information processing by cochlear implant users |
| Date of disclosure of the study information | 2023/09/29 |
| Last modified on | 2023/09/29 17:57:48 |
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Basic information
Public title
Assessment of auditory temporal information processing by cochlear implant users
Acronym
CI temporal processing
Scientific Title
Assessment of auditory temporal information processing by cochlear implant users
Scientific Title:Acronym
CI temporal processing
Region
| Japan |
Condition
Condition
profound hearing loss (cochlear implant users)
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to conduct psychophysical measurements on cochlear implant (CI) users to establish methods for assessing auditory modulation frequency selectivity and other temporal information processing abilities, and to explore the relationship with the perception of sounds such as speech sounds and music. In addition, by comparing data obtained from participants with different histories of deafness and implantation, the relationship with the development and adaptation of central amplitude modulation processing mechanisms will be explored.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
auditory selectivity of modulation frequency
Key secondary outcomes
Pure tone/complex tone detection threshould, amplitude modulation detection threshold, frequency discrimination threshold, pitch identification accuracy, speech recognition performance
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
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cochlear implant (CI) users and normal-hearing subjects as comparators
CI users
(1) CI users aged between 15 years (*)*1 and 80 years at the time consent is obtained.
(2) Those who have given written consent of their own free will with full understanding of their participation in the study. In the case of minors (under 18 years of age), written consent must also be obtained from a substitute consenting party.
(3) Subjects who underwent CI implantation at Shizuoka Prefectural General Hospital.
(*1) Considering the subject's ability to give consent, it is desirable that the subject should be at least 18 years of age.
In the case of normal hearing people
(1) Aged between 18 and 80 years at the time of obtaining consent.
(2) All 250-8000 Hz hearing levels are below 20 dB in pure tone audiometry (conducted after consent has been obtained).
(3) Those who have fully understood and given their free and voluntary written consent to participate in the study.
Key exclusion criteria
none
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Takagi |
Organization
Shizuoka General Hospital
Division name
Department of Head and Neck Otolaryngology / Hearing Center
Zip code
420-8527
Address
4-27-1 Kita Andou, Aoi-ku, Shizuoka-shi, Shizuoka, Japan
TEL
054-247-6111
akira-takagi@i.shizuoka-pho.jp
Public contact
Name of contact person
| 1st name | Masako |
| Middle name | |
| Last name | Kanamaru |
Organization
Shizuoka General Hospital
Division name
Hearing Center
Zip code
420-8527
Address
4-27-1 Kita Andou, Aoi-ku, Shizuoka-shi, Shizuoka, Japan
TEL
054-247-6111
Homepage URL
akira-takagi@i.shizuoka-pho.jp
Sponsor or person
Institute
Shizuoka General Hospital, Hearing Center
Institute
Department
Personal name
Akira Takagi
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Shizuoka Graduate University of Public Health, NTT Communication Science Laboratories
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka General Hospital Clinical Research Ethics Committee
Address
4-27-1 Kita Andou, Aoi-ku, Shizuoka-shi, Shizuoka, Japan
Tel
N/A
N/A
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
| 2023 | Year | 09 | Month | 29 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 29 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Amplitude modulation detection task for acoustic stimuli (perceptual testing)
Management information
Registered date
| 2023 | Year | 09 | Month | 29 | Day |
Last modified on
| 2023 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059488
