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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000028392 |
Receipt No. | R000032506 |
Scientific Title | Exploratory study on word intelligibility in the presence of competing speech for subjects with auditory processing disorders and healthy subjects |
Date of disclosure of the study information | 2017/07/27 |
Last modified on | 2018/06/11 |
Basic information | ||
Public title | Exploratory study on word intelligibility in the presence of competing speech for subjects with auditory processing disorders and healthy subjects | |
Acronym | Word intelligibility in presence of competing speech | |
Scientific Title | Exploratory study on word intelligibility in the presence of competing speech for subjects with auditory processing disorders and healthy subjects | |
Scientific Title:Acronym | Word intelligibility in presence of competing speech | |
Region |
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Condition | ||
Condition | 1) healthy subjects
2) auditory processing disorders |
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Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Preliminary investigation for establishment of objective evaluation of hearing difficulty in patients with auditory processing disorders |
Basic objectives2 | Others |
Basic objectives -Others | Establishment of objective evaluation |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Others |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Word intelligibility |
Key secondary outcomes |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | No treatment |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Prevention | |
Type of intervention |
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Interventions/Control_1 | Healthy subjects/Word intelligibility test | |
Interventions/Control_2 | APD patients/Word intelligibility test | |
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 | 1) Hearing test subjects:
20 subjects with normal hearing participated in the study as a volunteer who agree with the purpose of the research and satisfied the following conditions a) and b) a) age: 20 years old or older than 20 years, and younger than 40 years old b)performance status = 0 2)Patients with APD: 20 patients diagnosed with APD (including suspicious cases) who intend to participate as a volunteer in this study and satisfy the following conditions a), b), c) a) age: 20 years old or older than 20 years, and younger than 40 years old b) age: 15 years old or older than 15 years, and younger than 20 years old patients who got consent from the parent or guardian for examination c) Performance status 0 |
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Key exclusion criteria | I) Healthy subjects
1) Past history of the ear disease 2) Subjects with past history of mental disease 3) Subjects with past history of the peripheral or central neurologic disease 4) Subjects with the possibility of the pregnancy 5) Subjects whom researchers judged to be inappropriate II) patients with APD 1) Subjects with the possibility of the pregnancy 2) Subjects whom researchers judged to be inappropriate |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Tohoku University | ||||||
Division name | Graduate School of Biomedical Engineering | ||||||
Zip code | |||||||
Address | 1-1 Seiryo-machi, Aoba-ku, Sendai | ||||||
TEL | 022-717-7303 | ||||||
kawase@orl.med.tohoku.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Tohoku University | ||||||
Division name | Graduate School of Biomedical Engineering | ||||||
Zip code | |||||||
Address | 1-1 Seiryo-machi, Aoba-ku, Sendai | ||||||
TEL | 022-717-7303 | ||||||
Homepage URL | |||||||
kawase@orl.med.tohoku.ac.jp |
Sponsor | |
Institute | Tohoku University |
Institute | |
Department |
Funding Source | |
Organization | the Ministry of Education, Culture, Sports, Science and Technology-Japan |
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 | |
Address | |
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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 | |
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 | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
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=R000032506 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |