UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016581 |
|---|---|
| Receipt number | R000019027 |
| Scientific Title | Auditory evoked potential in patients with bilateral cochlear implantation |
| Date of disclosure of the study information | 2015/04/01 |
| Last modified on | 2017/03/27 19:19:56 |
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Basic information
Public title
Auditory evoked potential in patients with bilateral cochlear implantation
Acronym
AEP in bilateral CI patients
Scientific Title
Auditory evoked potential in patients with bilateral cochlear implantation
Scientific Title:Acronym
AEP in bilateral CI patients
Region
| Japan |
Condition
Condition
bilateral cochlear implant recipients
normal hearing subjects
Classification by specialty
| Oto-rhino-laryngology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To see the central auditory processing in patients with bilateral cochlear implant
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
N100 amplitude and latency
Key secondary outcomes
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Bilateral cochlear implant (Coclear ltd) recipients treated at Iwate Medical University or Kyoto University Hospital
Patients and normal subjects with informed consent or informed assent (at or younger than 10 years)
Key exclusion criteria
Patients and normal subjects without consent or assent
Patients and normal subjects who cannot tolerate the examination without sedative drugs
Target sample size
26
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Harukazu Hiraumi |
Organization
Iwate Medical University
Division name
Otolaryngology, Head and Neck Surgery
Zip code
Address
19-1, Uchimaru, Morioka, Iwate
TEL
019-651-5111
hhiraumi@ent.kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Harukazu Hiraumi |
Organization
Iwate Medical University
Division name
Otolaryngology, Head and Neck Surgery
Zip code
Address
19-1, Uchimaru, Morioka, Iwate
TEL
019-651-5111
Homepage URL
hhiraumi@ent.kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 04 | 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
Suspended
Date of protocol fixation
| 2013 | Year | 12 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Compare the amplitude and latency of N100 between the CI recipients and normal hearing sujbects
Management information
Registered date
| 2015 | Year | 02 | Month | 19 | Day |
Last modified on
| 2017 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019027
