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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010274
Receipt No. 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

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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
Institute Nara Medical University
Institute
Department

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
URL(English) https://upload.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


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