UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010274
Receipt number R000012018
Scientific Title Clinical research about bone-conducted ultrasonic hearing aid
Date of disclosure of the study information 2013/03/25
Last modified on 2020/05/12 14:13:34

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Basic information

Public title

Clinical research about bone-conducted ultrasonic hearing aid

Acronym

Clinical research about bone-conducted ultrasonic hearing aid

Scientific Title

Clinical research about bone-conducted ultrasonic hearing aid

Scientific Title:Acronym

Clinical research about bone-conducted ultrasonic hearing aid

Region

Japan


Condition

Condition

Sensorineural hearing loss

Classification by specialty

Oto-rhino-laryngology Rehabilitation medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Development of a hearing aid system using bone-conducted ultrasounds for profoundly hearing impaired patients

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Word recognition and monosyllable intelligibility using bone-conducted ultrasonic hearing aid

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

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Device,equipment Behavior,custom

Interventions/Control_1

Periodical training of hearing and utterance using bone-conducted ultrasonic hearing aid

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Sensorineural hearing loss patients who can detect bone-conducted ultrasounds

Key exclusion criteria

Person who cannot detect bone-conducted ultrasounds

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Hosoi

Organization

Nara Medical University

Division name

Department of Otorhinolaryngology - Head and neck surgery

Zip code

634-8522

Address

Shijo-cho 840, Kashihara, Nara, JAPAN

TEL

0744223051

Email

hosoi@naramed-u.ac.jp


Public contact

Name of contact person

1st name Tadashi
Middle name
Last name NIshimura

Organization

Nara Medical University

Division name

Department of Otorhinolaryngology - Head and neck surgery

Zip code

634-8522

Address

Shijo-cho 840, Kashihara, Nara, JAPAN

TEL

0744223051

Homepage URL


Email

t-nishim@naramed-u.ac.jp


Sponsor or person

Institute

Nara Medical University

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

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

IRB in Nara Medical Universtity

Address

Shijo-cho 840, Kashihara, Nara, JAPAN

Tel

0744-22-3051

Email

ychiken@naramed-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

2013 Year 03 Month 25 Day


Related information

URL releasing protocol

NA

Publication of results

Unpublished


Result

URL related to results and publications

NA

Number of participants that the trial has enrolled

2

Results

Bone conducted ultrasound was peceptable. Speech perception was improved after the trainning. However, its effects were insufficient.

Results date posted

2019 Year 03 Month 27 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

total deaf persons

Participant flow

Persons who wanted to participate the trial after the explanation.

Adverse events

None

Outcome measures

Speech perception

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2003 Year 12 Month 01 Day

Date of IRB

2003 Year 12 Month 01 Day

Anticipated trial start date

2004 Year 01 Month 01 Day

Last follow-up date

2013 Year 11 Month 01 Day

Date of closure to data entry

2013 Year 12 Month 31 Day

Date trial data considered complete

2013 Year 12 Month 31 Day

Date analysis concluded

2013 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 03 Month 19 Day

Last modified on

2020 Year 05 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012018


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name