UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The role of video Head Impulse Test to evaluation of semicircular canal function in healthy subjects
Title of the study (Brief title)	The role of video Head Impulse Test to evaluation of semicircular canal function in healthy subjects
Region	Japan

Condition
Condition	vertigo
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In the present study, an attempt was made to examine the role of video Head Impulse Test to evaluation of semicircular canal function in healthy subjects.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Canal paresis evaluated with video Head Impulse Test
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	To evaluate semicircular canal function with video Head Impulse Test in healthy subjects
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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Healthy adult subjects without history of vertigo/dizziness and cervical disease
Key exclusion criteria	1) Subjects who have ever suffered from vertigo/dizziness or cervical disease. 2) Subjects who was excluded by investigators.
Target sample size	20

Research contact person
Name of lead principal investigator	Noriaki Takeda
Organization	University of Tokushima School of Medicine
Division name	Department of Otolaryngology
Address	3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL	088-633-7169
Email	takeda@clin.med.tokushima-u.ac.jp

Public contact
Name of contact person	Noriaki Takeda
Organization	University of Tokushima School of Medicine
Division name	Department of Otolaryngology
Address	3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL	088-633-7169
Homepage URL
Email	takeda@clin.med.tokushima-u.ac.jp

Sponsor
Institute	University of Tokushima
Institute
Department

Funding Source
Organization	Grant-in-Aid from Ministry of Health and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2014 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 08 Month 13 Day
Anticipated trial start date	2014 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 09 Month 08 Day
Last modified on	2018 Year 03 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017557