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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021391
Receipt No. R000024618
Scientific Title Predictors of persistent postural-perceptual dizziness in new-onset benign paroxysmal positional vertigo: a prospective cohort study in Japanese tertiary setting
Date of disclosure of the study information 2016/03/09
Last modified on 2019/06/17

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Basic information
Public title Predictors of persistent postural-perceptual dizziness in new-onset benign paroxysmal positional vertigo: a prospective cohort study in Japanese tertiary setting
Acronym Predictors of persistent postural-perceptual dizziness in new-onset benign paroxysmal positional vertigo: a prospective cohort study in Japanese tertiary setting
Scientific Title Predictors of persistent postural-perceptual dizziness in new-onset benign paroxysmal positional vertigo: a prospective cohort study in Japanese tertiary setting
Scientific Title:Acronym Predictors of persistent postural-perceptual dizziness in new-onset benign paroxysmal positional vertigo: a prospective cohort study in Japanese tertiary setting
Region
Japan

Condition
Condition benign paroxysmal positional vertigo:BPPV
persistent postural-perceptual dizziness: PPPD
Classification by specialty
Psychiatry Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to examine the predictors of persistent postural-perceptual dizziness in new-onset benign paroxysmal positional vertigo.
Basic objectives2 Others
Basic objectives -Others The purpose of this study is to examine the predictors of persistent postural-perceptual dizziness in new-onset benign paroxysmal positional vertigo.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the onset of persistent postural-perceptual dizziness (PPPD)
Key secondary outcomes The following data, 1 month later and 4 months later from onset
Vertigo Symptom Scale-short form
Dizziness Handicap Inventory
Hospital Anxiety and Depression Scale
NEO Five Factor Inventory
Nystagmus

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) patients diagnosed as benign paroxysmal positional vertigo
2) from onset, after 28 days and 55 days
Key exclusion criteria 1) the patient who possesses PPPD already
2) the patient with BPPV in the past for 1 year
3) the patient with inner ear diseases
4) the patient for whom it's difficult to understand and continue
5) the patient with serious mental diseases
6) Other reasons inadequate for study participation
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Kayoko
Middle name
Last name Kabaya
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Otolaryngology - Head and Neck Surgery
Zip code 4678601
Address Mizuho-cho, Mizuho-ku, Nagoya 467-8601 JAPAN
TEL 052-853-8256
Email kabaya@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name Kayoko
Middle name
Last name Kabaya
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Otolaryngology - Head and Neck Surgery
Zip code 4678601
Address Mizuho-cho, Mizuho-ku, Nagoya 467-8601 JAPAN
TEL 052-853-8256
Homepage URL
Email kabaya@med.nagoya-cu.ac.jp

Sponsor
Institute Department of Otolaryngology - Head and Neck Surgery, Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Department of Otolaryngology - Head and Neck Surgery, Nagoya City University Graduate School of Medical Sciences
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 Clinical Research Management Center Nagoya City University Hospital
Address Kawasumi1 Mizuho-cho Mizuho-ku Nagoya, Aichi, Japan
Tel 052-851-5511
Email clinical_research@med.nagoya-cu.ac.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 名古屋市立大学病院(愛知県)
新潟大学医歯学総合病院 (新潟県)
埼玉医科大学病院 (埼玉県)
獨協医科大学越谷病院 (東京都)
帝京大学医学部付属溝口病院 (東京都)
東京慈恵会医科大学附属病院 (東京都)
奈良県立医科大学付属病院 (奈良県)
大阪大学医学部付属病院 (大阪府)
近畿大学医学部付属病院(大阪府)
鳥取大学医学部付属病院(鳥取県)
勤医協札幌病院 (北海道)
一宮市立市民病院 (愛知県)       

Other administrative information
Date of disclosure of the study information
2016 Year 03 Month 09 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
2016 Year 03 Month 02 Day
Date of IRB
2016 Year 03 Month 02 Day
Anticipated trial start date
2016 Year 03 Month 09 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information cohort study
All patients who filled with criteria for selecting during 3 years after March 9, 2016

Management information
Registered date
2016 Year 03 Month 08 Day
Last modified on
2019 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024618

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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