UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
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
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
URL(English) https://upload.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


Contact us.