UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014343 |
|---|---|
| Receipt number | 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 09:48:14 |
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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
| Japan |
Condition
Condition
peripheral vestibular disorders, sudden deafness, facial palsy
Classification by specialty
| Oto-rhino-laryngology |
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
Interventions/Control_1
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
| 10 | years-old | <= |
Age-upper limit
| Not applicable |
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
| 1st name | |
| Middle name | |
| Last name | Arata Horii |
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
| 1st name | |
| Middle name | |
| Last name | Arata Horii |
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 or person
Institute
Osaka national Hospital
Institute
Department
Personal name
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
| 2014 | Year | 06 | Month | 24 | Day |
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
| 2013 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 25 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2015 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
Postural contro is visually dependent in non-dizzy patients.
Management information
Registered date
| 2014 | Year | 06 | Month | 23 | Day |
Last modified on
| 2014 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016697
