UMIN-CTR Clinical Trial

Basic information
Public title	The recording of eye movement using portable recording system by patients themselves during vertigo attack
Acronym	The recording of eye movement using portable recording system by patients themselves during vertigo attack
Scientific Title	The recording of eye movement using portable recording system by patients themselves during vertigo attack
Scientific Title:Acronym	The recording of eye movement during vertigo attack
Region	Japan

Condition
Condition	Diseases of which complaint is vertigo attack
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To record and analyze the eye movement during vertigo attack
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Recorded movie of eye movement
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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Device for recording eye movement
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients who assent this study and can use the device of this study at home.
Key exclusion criteria	# Patients who do not assent this study. # Patients who can not use the device of this study at home. # Patients whose contact information is unclear. # Patients who are judged to be unsuitable to this study by doctors.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Takao Middle name Last name Imai
Organization	Bell Land General Hospital
Division name	Otorhinolaryngology - Head and Neck Surgery
Zip code	5998247
Address	500-3 Higashiyama, Naka-ku, Sakai-shi, Osaka, Japan
TEL	072-234-2001
Email	t_imai@seichokai.or.jp

Public contact
Name of contact person	1st name Takao Middle name Last name Imai
Organization	Bell Land General Hospital
Division name	Otorhinolaryngology - Head and Neck Surgery
Zip code	5998247
Address	500-3 Higashiyama, Naka-ku, Sakai-shi, Osaka, Japan
TEL	072-234-2001
Homepage URL
Email	t_imai@seichokai.or.jp

Sponsor
Institute	Department of Otorhinolaryngology - Head and Neck Surgery, Bell Land General Hospital
Institute
Department

Funding Source
Organization	Japan society for the promotion of science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Research ethics committee, Bell Land General Hospital
Address	500-3 Higashiyama, Naka-ku, Sakai-shi, Osaka, Japan
Tel	072-234-2001
Email	irb@bh.seichokai.or.jp

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	2022 Year 11 Month 29 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
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	Open public recruiting
Date of protocol fixation	2022 Year 10 Month 21 Day
Date of IRB	2022 Year 10 Month 21 Day
Anticipated trial start date	2022 Year 10 Month 22 Day
Last follow-up date	2027 Year 10 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 11 Month 28 Day
Last modified on	2022 Year 11 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056516