UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020665 |
|---|---|
| Receipt number | R000023843 |
| Scientific Title | Effect of auditory and cognition training to speech perception |
| Date of disclosure of the study information | 2016/01/21 |
| Last modified on | 2017/01/21 14:18:14 |
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Basic information
Public title
Effect of auditory and cognition training to speech perception
Acronym
Study of auditory training
Scientific Title
Effect of auditory and cognition training to speech perception
Scientific Title:Acronym
Study of auditory training
Region
| Japan |
Condition
Condition
Presbycusis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of auditory and cognitive training for the speech perception.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Speech perception in noise and quiet 10 days, 1 month, 2 months, and 4 month after training.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention group will have the original auditory and cognitive training program in the i-pad for 10 days, 1 month, 2 months, 4 months. They will do the training for about 20 minutes every day
Interventions/Control_2
This group will have the number puzzle and do the puzzle for 20 minutes.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adults who have no apparent sign of cognitive defect.
Key exclusion criteria
Those who have cognitive problem
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsuya Yamasoba |
Organization
The University of Tokyo Hospital
Division name
Otolaryngology
Zip code
Address
7-3-1 Hongo Bunkyo-ku Tokyo Japan
TEL
03-5800-8665
tyamasoba-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akinori Kashio |
Organization
The University of Tokyo Hospital
Division name
Otolaryngology
Zip code
Address
7-3-1 Hongo Bunkyo-ku Tokyo Japan
TEL
03-5800-8665
Homepage URL
kashioa-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
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 | 21 | 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
| 2015 | Year | 10 | Month | 01 | 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 | 20 | Day |
Last modified on
| 2017 | Year | 01 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023843
