UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Spatiotemporal pathology analysis of Meniere's disease using mobile health technology
Title of the study (Brief title)	Spatiotemporal pathology analysis of Meniere's diseas
Region	Japan

Condition
Condition	Meniere's disease
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Meniere's disease is a disease that is rich in temporal and spatial change, and it aims to analyze its condition.
Basic objectives2	Others
Basic objectives -Others	Evaluate hearing ability and nystagmus findings of patients with Meniere's disease.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase

Assessment
Primary outcomes	Nystagmus findings and hearing value.
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	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	Evaluate vestibular function using portable eye movement recording device.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Meniere's disease patients repeating dizzy attacks.
Key exclusion criteria	An underage patient, a patient with dementia.
Target sample size	20

Research contact person
Name of lead principal investigator	Tatsuro Sekine
Organization	Saitama Medical University
Division name	Otolaryngology
Address	38 Morohongo, Moroyama-cho, Saitama
TEL	0492761111
Email	tatsuroskn@gmail.com

Public contact
Name of contact person	Tatsuro Sekine
Organization	Saitama Medical University
Division name	Otolaryngology
Address	38 Morohongo, Moroyama-cho, Saitama
TEL	0492761111
Homepage URL
Email	tatsuroskn@gmail.com

Sponsor
Institute	Saitama Medical University
Institute
Department

Funding Source
Organization	Saitama Medical University
Organization
Division
Category of Funding Organization	Other
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	2018 Year 07 Month 02 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 08 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	2018 Year 07 Month 02 Day
Last modified on	2018 Year 07 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037907