UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041197
Receipt number R000046694
Scientific Title Survey of actual conditions for the hearing impaired and examination of the usefulness of intervention with new hearing aid or speech to text, voice recognition technology
Date of disclosure of the study information 2020/08/01
Last modified on 2020/07/22 18:01:31

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Basic information

Public title

Survey of actual conditions for the hearing impaired and examination of the usefulness of intervention with new hearing aid or speech to text, voice recognition technology

Acronym

Survey of actual conditions for the hearing impaired and the usefulness of intervention with hearing aid or voice recognition technology

Scientific Title

Survey of actual conditions for the hearing impaired and examination of the usefulness of intervention with new hearing aid or speech to text, voice recognition technology

Scientific Title:Acronym

Survey of actual conditions for the hearing impaired and the usefulness of intervention with hearing aid or voice recognition technology

Region

Japan


Condition

Condition

hearing loss

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

1.Assess the difficulty of the hearing impaired
2.Verify the improvement of QOL and the improvement of understanding and processing speed of information by intervention with new hearing aid or speech to text, voice recognition
3.Verify the significance of hearing aid for people with unilateral hearing impaired

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Hearing Environments and Reflection on Quality of Life (HEAR-QL-28)
Hearing Handicap Inventory for Adults(HHIA)
Communication Profile for the Hearing Impaired (CPHI)

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

Educational,Counseling,Training

Type of intervention

Other

Interventions/Control_1

new hearing aid
speech to text voice recognition technology

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

10 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

bilateral hearing loss
unilateral hearing loss
auditory processing disorder

Key exclusion criteria

none

Target sample size

60


Research contact person

Name of lead principal investigator

1st name Yuko
Middle name
Last name Kataoka

Organization

Okayama University Hospital

Division name

Otorhinolaryngology

Zip code

700-8558

Address

2-5-1 Shikata-Cho Kitaku Okayama City

TEL

086-235-7307

Email

yu-kat@cc.okayama-u.ac.jp


Public contact

Name of contact person

1st name Yuko
Middle name
Last name Kataoka

Organization

Okayama University Hospital

Division name

Otorhinolaryngology

Zip code

700-8558

Address

2-5-1 Shikata-Cho Kitaku Okayama City

TEL

086-235-7307

Homepage URL


Email

yu-kat@cc.okayama-u.ac.jp


Sponsor or person

Institute

Ministry of Health, Labour and Welfare

Institute

Department

Personal name



Funding Source

Organization

Ministry of Health, Labour and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Okayama University Hospital

Address

2-5-1 Shikata-Cho Kitaku Okayama City

Tel

086-235-7307

Email

jibika@cc.okayama-u.ac.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

2020 Year 08 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

Preinitiation

Date of protocol fixation

2020 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2020 Year 08 Month 01 Day

Last follow-up date

2023 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 07 Month 22 Day

Last modified on

2020 Year 07 Month 22 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046694


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name