UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018684 |
|---|---|
| Receipt number | R000021627 |
| Scientific Title | Analysis on effect of cognitive function by hearing aid insertion to thepatients with mild to moderate hearing lossd |
| Date of disclosure of the study information | 2015/08/15 |
| Last modified on | 2020/08/18 17:04:58 |
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Basic information
Public title
Analysis on effect of cognitive function by hearing aid insertion to thepatients with mild to moderate hearing lossd
Acronym
Analysis on effect of cognitive function and hearing aid insertion
Scientific Title
Analysis on effect of cognitive function by hearing aid insertion to thepatients with mild to moderate hearing lossd
Scientific Title:Acronym
Analysis on effect of cognitive function and hearing aid insertion
Region
| Japan |
Condition
Condition
the patients with mild and moderate hearing loss
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
can hearing aid improve cognitive function?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
cognitive function
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
hearing aid insertion time
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
normal cognitive function
Key exclusion criteria
dementia patients
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Ogawa |
Organization
Keio university, School of medicine
Division name
Dept. Otolaryngology
Zip code
1608586
Address
35 Shinanomachi Shinjuku
TEL
0353633827
skan@a7.keio.jp
Public contact
Name of contact person
| 1st name | Sho |
| Middle name | |
| Last name | Kanzaki |
Organization
Keio University
Division name
Dept. Otolaryngology
Zip code
160-8586
Address
Shinjuku
TEL
+81353633827
Homepage URL
skan@keio.jp
Sponsor or person
Institute
Dept. Otolaryngology, Keio university, School of medicine
Institute
Department
Personal name
Funding Source
Organization
other
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
Keio University
Address
35 Shinanomachi Shinjuku Tokyo
Tel
0353633827
skan@keio.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
| 2015 | Year | 08 | Month | 15 | 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
| 2015 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 15 | Day |
Last modified on
| 2020 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021627
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
