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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033252
Receipt No. R000037907
Scientific Title Spatiotemporal pathology analysis of Meniere's disease using mobile health technology
Date of disclosure of the study information 2018/07/02
Last modified on 2018/07/02

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Basic information
Public title Spatiotemporal pathology analysis of Meniere's disease using mobile health technology
Acronym Spatiotemporal pathology analysis of Meniere's diseas
Scientific Title Spatiotemporal pathology analysis of Meniere's disease using mobile health technology
Scientific Title:Acronym 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
1st name
Middle name
Last name Tatsuro Sekine
Organization Saitama Medical University
Division name Otolaryngology
Zip code
Address 38 Morohongo, Moroyama-cho, Saitama
TEL 0492761111
Email tatsuroskn@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuro Sekine
Organization Saitama Medical University
Division name Otolaryngology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 Preinitiation
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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