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

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 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

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

Value
https://center6.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