UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045570 |
|---|---|
| Receipt number | R000052020 |
| Scientific Title | Categorical perception of voiced plosives and speech perception in cochlear implant users. |
| Date of disclosure of the study information | 2021/09/27 |
| Last modified on | 2022/04/12 18:08:11 |
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Basic information
Public title
Categorical perception of voiced plosives and speech perception in cochlear implant users.
Acronym
Categorical perception of voiced plosives and speech perception in cochlear implant users.
Scientific Title
Categorical perception of voiced plosives and speech perception in cochlear implant users.
Scientific Title:Acronym
Categorical perception of voiced plosives and speech perception in cochlear implant users.
Region
| Japan |
Condition
Condition
Congenital severe to profound hearing loss.
Cochlear implant user.
Classification by specialty
| Oto-rhino-laryngology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate perception of acoustic cues to place of articulation in cochlear implant users who received implant in early childhood.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Results of identification task and discrimination task on synthetic voice. Results of speech perception test.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
hearing test
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
| 11 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Congenital hearing loss.
Received cochlear implant in childhood.
10 years over after received implant.
Key exclusion criteria
Progressive hearing loss.
Acquired hearing loss.
Can understand the test .
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | UEDA |
Organization
Shizuoka General Hospital
International University of Health and Welfare graduate school master course
Division name
Otolaringology Speech therapy and audiology division
Zip code
420-8527
Address
4-27-1 Aoi-ward, Shizuoka-city, Shizuoka
TEL
054-247-6111
yuko-ueda@i.shizuoka-pho.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | UEDA |
Organization
Shizuoka General Hospital/International University of Health and Welfare graduate school master cour
Division name
Otolaringology ,Speech therapy and audiology division
Zip code
420-8527
Address
4-27-1 Aoi-ward, Shizuoka-city, Shizuoka
TEL
0542476111
Homepage URL
yuko-ueda@i.shizuoka-pho.jp
Sponsor or person
Institute
Shizuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare Graduate School
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
Shizuoka General Hospital Research Ethical Committee
Address
4-27-1 Aoi-ward,Shizuoka-city,Shizuoka
Tel
0542476111
chiken-sougou@shizuoka-pho.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
静岡県立総合病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
45
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
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 25 | Day |
Last modified on
| 2022 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052020
