UMIN-CTR Clinical Trial

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
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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
Email	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
Email	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
Email

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
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Baseline Characteristics
Participant flow
Adverse events
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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
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
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