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
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
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
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
