UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058635 |
|---|---|
| Receipt number | R000067051 |
| Scientific Title | An investigation on the feasibility of cochlear implant remote mapping. |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/29 16:30:16 |
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Basic information
Public title
An investigation on the feasibility of cochlear implant remote mapping.
Acronym
An investigation on the feasibility of cochlear implant remote mapping.
Scientific Title
An investigation on the feasibility of cochlear implant remote mapping.
Scientific Title:Acronym
An investigation on the feasibility of cochlear implant remote mapping.
Region
| Japan |
Condition
Condition
hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the efficacy of remote mapping with that of face-to-face mapping for cochlear implant recipients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Travel time to the hospital
Key secondary outcomes
Speech perception
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who live in the southern part of Nagano prefecture and use MED-EL cochlear implants
Key exclusion criteria
1. Patients whose facial nerve spasm is occuring by electrical stimulation.
2. Patients whose cognitive function has deteriorated.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Gonda |
Organization
Shinshu University Hospital
Division name
Department of Otorhinolaryngology-Head and Neck Surgery
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2666
ayagon@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Gonda |
Organization
Shinshu University Hospital
Division name
Department of Otorhinolaryngology-Head and Neck Surgery
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2666
Homepage URL
ayagon@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Iida Municipal Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine Life Sciences and Medical Research Ethics Committee
Address
3-1-1 Asahi. Matsumoto, Nagano
Tel
0263-37-3099
mdrinri@shinshu-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
| 2025 | 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
| 2025 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 07 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2025 | Year | 07 | Month | 29 | Day |
Last modified on
| 2025 | Year | 07 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067051
