UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020721
Receipt number R000023909
Scientific Title analysis on cognition effectiveness of hearing aid and cochlear implant to the patients with hearing loss
Date of disclosure of the study information 2016/01/31
Last modified on 2016/03/06 22:46:52

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Basic information

Public title

analysis on cognition effectiveness of hearing aid and cochlear implant to the patients with hearing loss

Acronym

analysis on cognition effectiveness of hearing aid and cochlear implant

Scientific Title

analysis on cognition effectiveness of hearing aid and cochlear implant to the patients with hearing loss

Scientific Title:Acronym

analysis on cognition effectiveness of hearing aid and cochlear implant

Region

Japan


Condition

Condition

patients with hearing loss

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The cognitive functions are tested to the patients with hearing loss. The changes of cognition are compared between before and after hearing aids and cochlear implants.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

evaluation of cognition before and 12 months after hearing re-acquisition.

Key secondary outcomes

evaluation of cognition before and 6 months after hearing re-acquisition.


Base

Study type

Interventional


Study design

Basic design

Factorial

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

long time of hearing aids or cochlear implants

Interventions/Control_2

short time of hearing aids or cochlear implants

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


Not applicable

Gender

Male and Female

Key inclusion criteria

patients with hearing aids or cochlear implants

Key exclusion criteria

1 the patints without any physical problems
2 the patints without any tinnitus treatments
3 the patints without severe complications or psychogenic problems

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Sho Kanzaki

Organization

Keio University Hospital

Division name

otolaryngology

Zip code


Address

35 shinanomachi shinjuku

TEL

03-5363-3827

Email

skan@a7.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Sho Kanzaki

Organization

Keio University Hospital

Division name

otolaryngology

Zip code


Address

35 shinanomachi shinjuku

TEL

03-5363-3827

Homepage URL


Email

skan@a7.keio.jp


Sponsor or person

Institute

Japan Agency for Medical Research and Development

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

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


Address


Tel


Email



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 31 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

Preinitiation

Date of protocol fixation

2016 Year 01 Month 21 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 25 Day

Last modified on

2016 Year 03 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023909


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name