UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035605
Receipt number R000040569
Scientific Title Investigation of validity and reliability of new interview sheet for diagnosis of benign paroxysmal positional vertigo
Date of disclosure of the study information 2019/02/01
Last modified on 2020/07/27 09:23:55

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Basic information

Public title

Investigation of validity and reliability of new interview sheet for diagnosis of benign paroxysmal positional vertigo

Acronym

Investigation of new interview sheet for BPPV

Scientific Title

Investigation of validity and reliability of new interview sheet for diagnosis of benign paroxysmal positional vertigo

Scientific Title:Acronym

Investigation of new interview sheet for BPPV

Region

Japan Asia(except Japan)


Condition

Condition

Disease of which complaint is dizziness and/or vertigo

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the efficacy of our interview sheet for diagnosis of benign paroxysmal positional vertigo in Japan and China

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

The sensitivity and specificity of our interview sheet for diagnosis of benign paroxysmal positional vertigo

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

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Other

Interventions/Control_1

Medical interview

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

95 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients whose chief complaint is dizziness and/or vertigo and who is obtained for consent of participation of this study

Key exclusion criteria

Patients who is not obtained for consent of participation of this study

Target sample size

470


Research contact person

Name of lead principal investigator

1st name Takao
Middle name
Last name Imai

Organization

Osaka University Graduate School of Medicine

Division name

Otorhinolaryngology - Head and Neck Surgery

Zip code

565-0871

Address

Suita-shi

TEL

06-6879-3951

Email

timai@ent.med.osaka-u.ac.jp


Public contact

Name of contact person

1st name Takao
Middle name
Last name Imai

Organization

Osaka University Graduate School of Medicine

Division name

Otorhinolaryngology - Head and Neck Surgery

Zip code

565-0871

Address

Suita-shi

TEL

06-6879-3951

Homepage URL


Email

timai@ent.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University

Institute

Department

Personal name



Funding Source

Organization

JSPS KAKENHI Gran

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

Osaka University Graduate School of Medicine

Address

2-2 Yamadaoka, Suita-shi

Tel

06-6210-8296

Email

rinri@hp-crc.med.osaka-u.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

BPPV2018

Org. issuing International ID_1

Sir Run Run Shaw Hospital, Medical College of Zhejiang University

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2019 Year 02 Month 01 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

2019 Year 01 Month 21 Day

Date of IRB

2019 Year 01 Month 28 Day

Anticipated trial start date

2019 Year 02 Month 01 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2019 Year 01 Month 21 Day

Last modified on

2020 Year 07 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040569


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name