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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000024706
Receipt No. 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

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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
Email 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
Email shujirominami@me.com

Sponsor
Institute National Tokyo Medical Center
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028426

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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