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UMIN-CTR Clinical Trial |
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Name | UMIN ID |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000014343 |
Receipt No. | R000016697 |
Scientific Title | Vestibular function in neuro-otologic diseases |
Date of disclosure of the study information | 2014/06/24 |
Last modified on | 2014/06/23 |
Basic information | ||
Public title | Vestibular function in neuro-otologic diseases | |
Acronym | Vestibular function in neuro-otologic diseases | |
Scientific Title | Vestibular function in neuro-otologic diseases | |
Scientific Title:Acronym | Vestibular function in neuro-otologic diseases | |
Region |
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Condition | ||
Condition | peripheral vestibular disorders, sudden deafness, facial palsy | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To investigate vestibular function in inner ear diseases |
Basic objectives2 | Others |
Basic objectives -Others | To correlate vestibular function with prognosis of primary disease in neuro-otologic diseases. To investigate visual or somatosensory dependence of postural control in neuro-otologic diseases |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Caloric response, pure tone audiogram, postural test |
Key secondary outcomes | facial nerve function |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
No. of arms | |
Purpose of intervention | |
Type of intervention | |
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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 | vertigo/dizziness patients who have periheral vestibular diseases. Non-vertigo/dizziness patients who have inner ear diseases | |||
Key exclusion criteria | Central vestibular diseases | |||
Target sample size | 300 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Osaka National Hospital | ||||||
Division name | Otolaryngology | ||||||
Zip code | |||||||
Address | 2-1-14 Hoenzaka, Chuo-ku, Osaka City | ||||||
TEL | 06-6942-1331 | ||||||
ahorii@ent.med.osaka-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Osaka National Hospital | ||||||
Division name | Otolaryngology | ||||||
Zip code | |||||||
Address | 2-1-14 Hoenzaka, Chuo-ku, Osaka City | ||||||
TEL | 06-6942-1331 | ||||||
Homepage URL | |||||||
ahorii@ent.med.osaka-u.ac.jp |
Sponsor | |
Institute | Osaka national Hospital |
Institute | |
Department |
Funding Source | |
Organization | Not available |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | Not available |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | YES |
Study ID_1 | 13093 |
Org. issuing International ID_1 | osaka National Hospital |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions | 国立病院機構大阪医療センター(大阪府) |
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 | Vestibular function is not a predictor of prognosis of the primary disease. Postural control is shifted from visual to somatosensory dependence in dizzy patients. |
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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information | Postural contro is visually dependent in non-dizzy patients. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016697 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |