UMIN-CTR Clinical Trial

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	No longer 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	2020 Year 06 Month 30 Day
Date trial data considered complete	2020 Year 07 Month 31 Day
Date analysis concluded	2021 Year 03 Month 31 Day

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	2022 Year 01 Month 03 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000024618