UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021391
Receipt number 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 2022/01/03 20:28:49

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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