UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017310
Receipt number R000020080
Scientific Title The frequency selectivity and temporal resolution measurement in hearing loss.
Date of disclosure of the study information 2015/04/28
Last modified on 2023/05/04 09:16:37

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Basic information

Public title

The frequency selectivity and temporal resolution measurement in hearing loss.

Acronym

The frequency selectivity and temporal resolution measurement in hearing loss.

Scientific Title

The frequency selectivity and temporal resolution measurement in hearing loss.

Scientific Title:Acronym

The frequency selectivity and temporal resolution measurement in hearing loss.

Region

Japan


Condition

Condition

sensorineural hearing loss

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study was to evaluate between frequency selectivity and temporal resolution in patients with sensorineural hearing loss.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

frequency selectivity and temporal resolution.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

hearing loss

Interventions/Control_2

normal hearing

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

80 years-old >=

Gender

Male and Female

Key inclusion criteria

sensorineural hearing loss

Key exclusion criteria

Severe hearing loss

Target sample size

60


Research contact person

Name of lead principal investigator

1st name sho
Middle name
Last name Kanzaki

Organization

School of Medicine, Keio University

Division name

Otorhinolaryngology

Zip code

1608582

Address

35 Shinanomachi Shinjyuku-ku Tokyo

TEL

0333531211

Email

shokanza@gmail.com


Public contact

Name of contact person

1st name Yasuhide
Middle name
Last name Okamoto

Organization

School of Medicine, Keio University

Division name

Otorhinolaryngology

Zip code

1608582

Address

35 Shinanomachi Shinjyuku-ku Tokyo

TEL

0333531211

Homepage URL


Email

okamotoy.10@kdt.biglobe.ne.jp


Sponsor or person

Institute

School of Medicine, Keio University

Institute

Department

Personal name



Funding Source

Organization

School of Medicine, Keio University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

School of Medicine, Keio University

Address

35 Shinanomachi Shinjyuku-ku Tokyo

Tel

0333531211

Email

shokanza@gmail.com


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

2015 Year 04 Month 28 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

Completed

Date of protocol fixation

2012 Year 10 Month 23 Day

Date of IRB

2012 Year 03 Month 29 Day

Anticipated trial start date

2012 Year 10 Month 23 Day

Last follow-up date

2023 Year 05 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded

2023 Year 05 Month 01 Day


Other

Other related information



Management information

Registered date

2015 Year 04 Month 28 Day

Last modified on

2023 Year 05 Month 04 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020080


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name