UMIN-CTR Clinical Trial
| 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 (Ver. 7) |
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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 |
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| Condition | |||
| Condition | Sensorineural hearing loss | ||
| Classification by specialty |
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| 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 |
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| 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 |
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| Age-upper limit |
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| 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 |
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| 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 |
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| 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 | |
| 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 |
| 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 |
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| 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. |
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| Results date posted |
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| Results Delayed | |||||||
| Results Delay Reason | |||||||
| Date of the first journal publication of results | |||||||
| Baseline Characteristics | total deaf persons |
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| Participant flow | Persons who wanted to participate the trial after the explanation. |
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| Adverse events | None |
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| Outcome measures | Speech perception |
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| Plan to share IPD | |||||||
| IPD sharing Plan description | |||||||
| Progress | |||||||
| Recruitment status | Completed | ||||||
| Date of protocol fixation |
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| Date of IRB |
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| Anticipated trial start date |
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| Last follow-up date |
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| Date of closure to data entry |
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| Date trial data considered complete |
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| Date analysis concluded |
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| Other | |
| Other related information | |
| Management information | |||||||
| Registered date |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012018 |
