UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008907 |
|---|---|
| Receipt number | R000010449 |
| Scientific Title | Effect of cochlear implant in patients with unilateral severe hearing loss and tinnitus |
| Date of disclosure of the study information | 2012/09/12 |
| Last modified on | 2013/09/12 14:25:03 |
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Basic information
Public title
Effect of cochlear implant in patients with unilateral severe hearing loss and tinnitus
Acronym
Effect of cochlear implant in patients with unilateral severe hearing loss and tinnitus
Scientific Title
Effect of cochlear implant in patients with unilateral severe hearing loss and tinnitus
Scientific Title:Acronym
Effect of cochlear implant in patients with unilateral severe hearing loss and tinnitus
Region
| Japan |
Condition
Condition
unilateral severe hearing loss and tinnitus
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
evaluate effects of cochlear implant for patients with unilateral severe hearing loss and tinnitus
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
improvement effects of tinnitus after cochlear implant
Key secondary outcomes
improvement effects of unilateral severe hearing loss after cochlear implant
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
cochlear implant
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
acquired severe hearing loss (higher than 70dBHL or less than 30% speech discrimination)
Key exclusion criteria
post meningitis, anomaly of cochlear, etc
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Seiichi Shinden |
Organization
Saiseikai Utsunomiya Hospital
Division name
Otolaryngology
Zip code
Address
911-1, Takebayashimachi, Utsunomiya
TEL
028-626-5500
seiichi_shinden@saimiya.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seiichi Shinden |
Organization
Saiseikai Utsunomiya Hospital
Division name
Otolaryngology
Zip code
Address
911-1,Takebayashimachi, Utsunomiya, Japan
TEL
028-626-5500
Homepage URL
seiichi_shinden@saimiya.com
Sponsor or person
Institute
Department of Otolaryngology, Saiseikai Utsunomiya Hospital
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
Department of Otolaryngology in Keio University and Shinshu University
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
済生会宇都宮病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 12 | 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
| 2012 | Year | 09 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 11 | 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
| 2012 | Year | 09 | Month | 12 | Day |
Last modified on
| 2013 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010449
