UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032019 |
|---|---|
| Receipt number | R000036540 |
| Scientific Title | Spatial Hearing in bilateral Cochlear implants |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2023/04/03 18:38:22 |
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Basic information
Public title
Spatial Hearing in bilateral Cochlear implants
Acronym
Spatial Hearing in bilateral Cochlear implants
Scientific Title
Spatial Hearing in bilateral Cochlear implants
Scientific Title:Acronym
Spatial Hearing in bilateral Cochlear implants
Region
| Japan |
Condition
Condition
bilateral sensorineural hearing loss
Classification by specialty
| Clinical immunology | Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate binaural sensitivity, spatial hearing and speech intelligibility under conditions with varying control of binaural cues to assess how well we can restore binaural cues or improve performance with CI processors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The goal of the studies in this protocol
is to provide information about bilateral use of CI.
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
Educational,Counseling,Training
Type of intervention
| Other |
Interventions/Control_1
Audioligy 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
| 8 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects will be adults (age 18+) who (a) have received or are scheduled to receive one or more cochlear implants in order to be able to hear, (b) have undergone or are scheduled to undergo corrective surgery to restore hearing, or (c) who wear hearing aids. Subjects who have one cochlear implant for single-sided deafness will have no more than mild to moderate hearing loss in the non-implanted ear. Subjects will have no other known disability, and will primarily use oral language.
Key exclusion criteria
People who do not use oral language will be excluded. Individuals who have a cochlear implant, hearing aid, or surgical correction in only one ear may be excluded from this study if the other ear has more than moderate hearing loss. Individuals who have cochlear implants made by manufacturers other than Cochlear Corporation or Advanced Bionics will not participate in experiments in Objective 1, as our lab currently has research platforms provided only by those two manufacturers. The research platforms are only compatible with cochlear implants manufactured by the providing company.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Tadao |
| Middle name | |
| Last name | Yoshida |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Otorhinolaryngology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2323
tadaoy@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadao |
| Middle name | |
| Last name | Yoshida |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Otorhinolaryngology
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2323
Homepage URL
tadaoy@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine, Department of Otorhinolaryngology
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine, Department of Otorhinolaryngology
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
Department of Ethics Review Committee
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-741-2111
ethics@med.nagoya-u.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
| 2018 | Year | 08 | Month | 01 | 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
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 30 | Day |
Last modified on
| 2023 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036540
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
