UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023737
Receipt number R000027345
Scientific Title Novel tests to detect the cause and the lesion in patients with dizziness
Date of disclosure of the study information 2016/10/03
Last modified on 2023/08/29 22:38:50

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Novel tests to detect the cause and the lesion in patients with dizziness

Acronym

Novel tests for dizziness

Scientific Title

Novel tests to detect the cause and the lesion in patients with dizziness

Scientific Title:Acronym

Novel tests for dizziness

Region

Japan


Condition

Condition

idiopathic dizziness or vertigo

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To detect the cause and the lesion in patients with idiopathic dizziness or vertigo

Basic objectives2

Others

Basic objectives -Others

1.the detection of lesion in video Head Impulse Test, 2.the detection of CTP from middle ear, 3.the detection of antibody against inner ear

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The percentage: detected/(detected + not detected)x100 in video Head Impulse Test, the detection of CTP from middle ear and the detection of antibody against inner ear

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

Device,equipment Maneuver

Interventions/Control_1

1.video Head Impulse Test
2.washing by saline in middle ear through a penetration of tympanic membrane (0,3mL)
3.collecting of serum by blood sampling (0.5mL)

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

16 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.the patients who want to detect the caus and the lesion for dizziness or vertigo
2.age >= 16, any gender
3.the patients referred to Kyushu University Hospital or Chidoribashi General Hospital
4.imformed consented

Key exclusion criteria

5.to have allergy to local anesthesic agents
6.to have severe cervical spondylosis or dissection of vertebral artery
7.the patients without consent
8.others (the patients to be determined as inadequate candidate)

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Takashi
Middle name
Last name Nakagawa

Organization

Graduate School of Medical Sciences, Kyushu University

Division name

Department of Otorhinolaryngology

Zip code

812-8582

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka, JAPAN

TEL

092-642-5668

Email

nakataka@qent.med.kyushu-u.ac.jp


Public contact

Name of contact person

1st name Kazuhiko
Middle name
Last name Kubo

Organization

Kyushu University Hospital

Division name

Department of Otorhinolaryngology, Head and Neck Surgery

Zip code

812-8582

Address

3-1-1 Maidashi, Higashi-ku, Fukuoka, JAPAN

TEL

092-642-5668

Homepage URL


Email

kubokazu@qent.med.kyushu-u.ac.jp


Sponsor or person

Institute

Kyushu University

Institute

Department

Personal name



Funding Source

Organization

Self funding

Organization

Division

Category of Funding Organization

Self funding

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

2016 Year 10 Month 03 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 08 Month 08 Day

Date of IRB

2016 Year 08 Month 17 Day

Anticipated trial start date

2016 Year 10 Month 03 Day

Last follow-up date

2026 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

On going registration.


Management information

Registered date

2016 Year 08 Month 23 Day

Last modified on

2023 Year 08 Month 29 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027345


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name