UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020721 |
|---|---|
| Receipt number | R000023909 |
| Scientific Title | analysis on cognition effectiveness of hearing aid and cochlear implant to the patients with hearing loss |
| Date of disclosure of the study information | 2016/01/31 |
| Last modified on | 2016/03/06 22:46:52 |
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Basic information
Public title
analysis on cognition effectiveness of hearing aid and cochlear implant to the patients with hearing loss
Acronym
analysis on cognition effectiveness of hearing aid and cochlear implant
Scientific Title
analysis on cognition effectiveness of hearing aid and cochlear implant to the patients with hearing loss
Scientific Title:Acronym
analysis on cognition effectiveness of hearing aid and cochlear implant
Region
| Japan |
Condition
Condition
patients with hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The cognitive functions are tested to the patients with hearing loss. The changes of cognition are compared between before and after hearing aids and cochlear implants.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
evaluation of cognition before and 12 months after hearing re-acquisition.
Key secondary outcomes
evaluation of cognition before and 6 months after hearing re-acquisition.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
long time of hearing aids or cochlear implants
Interventions/Control_2
short time of hearing aids or cochlear implants
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
patients with hearing aids or cochlear implants
Key exclusion criteria
1 the patints without any physical problems
2 the patints without any tinnitus treatments
3 the patints without severe complications or psychogenic problems
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sho Kanzaki |
Organization
Keio University Hospital
Division name
otolaryngology
Zip code
Address
35 shinanomachi shinjuku
TEL
03-5363-3827
skan@a7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sho Kanzaki |
Organization
Keio University Hospital
Division name
otolaryngology
Zip code
Address
35 shinanomachi shinjuku
TEL
03-5363-3827
Homepage URL
skan@a7.keio.jp
Sponsor or person
Institute
Japan Agency for Medical Research and Development
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
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
| 2016 | Year | 01 | Month | 31 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | 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
Management information
Registered date
| 2016 | Year | 01 | Month | 25 | Day |
Last modified on
| 2016 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023909
