UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024706 |
|---|---|
| Receipt number | R000028426 |
| Scientific Title | language environment and cognitive function analysis for presbyacusis |
| Date of disclosure of the study information | 2017/01/01 |
| Last modified on | 2019/05/08 14:17:45 |
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Basic information
Public title
language environment and cognitive function analysis for presbyacusis
Acronym
language environment and cognitive function analysis for presbyacusis
Scientific Title
language environment and cognitive function analysis for presbyacusis
Scientific Title:Acronym
language environment and cognitive function analysis for presbyacusis
Region
| Japan |
Condition
Condition
Presbyacusis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the language environment and cognitive function of the patients with presbyacusis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
language environment and 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
Prevention
Type of intervention
| Other |
Interventions/Control_1
LENA(Language ENvironment Analysis)
CADi
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
Presbyacusis
Key exclusion criteria
no
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shujiro |
| Middle name | |
| Last name | Minami |
Organization
National Tokyo Medical Center
Division name
Department of Otoloryngology
Zip code
1528902
Address
2-5-1 Higashigaoka Meguroku Tokyo
TEL
03-3411-0111
shujirominami@me.com
Public contact
Name of contact person
| 1st name | Shujiro |
| Middle name | |
| Last name | SMinami |
Organization
National Tokyo Medical Center
Division name
Department of Otoloryngology
Zip code
152-8902
Address
2-5-1 Higashigaoka Meguroku Tokyo
TEL
03-3411-0111
Homepage URL
shujirominami@me.com
Sponsor or person
Institute
National Tokyo Medical Center
Institute
Department
Personal name
Funding Source
Organization
Pfizer Health Research Foundation.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Tokyo Medical Center
Address
2-5-1 Higashigaoka Meguroku Tokyo
Tel
03-3411-0111
auchimura@ntmc-hosp.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
| 2017 | Year | 01 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | 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
| 2016 | Year | 11 | Month | 04 | Day |
Last modified on
| 2019 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028426
