UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053715 |
|---|---|
| Receipt number | R000061293 |
| Scientific Title | A Study of Speech-Language Development and Auditory Biomarkers with Bilateral Cochlear Implants users |
| Date of disclosure of the study information | 2024/02/28 |
| Last modified on | 2024/02/26 20:01:06 |
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Basic information
Public title
A Study of Speech-Language Development and Auditory Biomarkers with Bilateral Cochlear Implants users
Acronym
A Study of Speech-Language Development and Auditory Biomarkers with Bilateral Cochlear Implants users
Scientific Title
A Study of Speech-Language Development and Auditory Biomarkers with Bilateral Cochlear Implants users
Scientific Title:Acronym
A Study of Speech-Language Development and Auditory Biomarkers with Bilateral Cochlear Implants users
Region
| Japan |
Condition
Condition
congenital hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By evaluating the binaural hearing effect after bilateral cochlear implantation, we aim to explore factors that maximize (or hinder) the effects of binaural implantation, such as improvements in sound source localization ability and ability to hear in noise.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sound localization ability
Key secondary outcomes
ability to hear in noise
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
| 4 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have undergone cochlear implantation and have attended speech language rehabilitation or hearing loss classes at our hospital.
1.After bilateral cochlear implantation.
2.Age four years or older at the time of obtaining consent.
3.Written informed consent is obtained from the individual or their guardian with sufficient understanding regarding participation in the research.
Key exclusion criteria
none
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Matsubara |
Organization
Shizuoka Graduate University of Public Health
Division name
Doctol course
Zip code
4200881
Address
4-27-2 Kitaando, Aoi Ward, Shizuoka City, Shizuoka Prefecture
TEL
054-295-5400
st.amatsubara@s-sph.ac.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Matsubara |
Organization
Shizuoka Graduate University of Public Health
Division name
Doctol course
Zip code
4200881
Address
4-27-2 Kitaando, Aoi Ward, Shizuoka City, Shizuoka Prefecture
TEL
054-295-5400
Homepage URL
st.amatsubara@s-sph.ac.jp
Sponsor or person
Institute
Shizuoka Graduate University of Public Health
Institute
Department
Personal name
Aya Matsubara
Funding Source
Organization
Shizuoka general hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Shizuoka general hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shizuoka Graduate University of Public Health
Address
4-27-2 Kitaando, Aoi Ward, Shizuoka City, Shizuoka Prefecture
Tel
054-295-5400
gh-hearing@i.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
| 2024 | Year | 02 | Month | 28 | 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
| 2023 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 09 | 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
none
Management information
Registered date
| 2024 | Year | 02 | Month | 26 | Day |
Last modified on
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061293
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
