UMIN-ICDS Clinical Trial

Public title

An observational study of the relationship between nystagmus findings during vertigo attacks at home and inner ear contrast-enhanced MRI findings in patients with recurrent vertigo attacks

Acronym

A study of the relationship between nystagmus at home and inner ear contrast-enhanced MRI

Scientific Title

An observational study of the relationship between nystagmus findings during vertigo attacks at home and inner ear contrast-enhanced MRI findings in patients with recurrent vertigo attacks

Scientific Title:Acronym

A study of the relationship between nystagmus at home and inner ear contrast-enhanced MRI

Region

Japan

Condition

Patients with recurrent paroxysmal vertigo attacks.

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Vertigo was classified as vertigo or dizziness in the past, but now it is classified as acute, episodic or paroxysmal, or chronic in terms of its mode of onset. Among these, paroxysmal vertigo is the most distressing because of its long duration and the degree of disruption of daily life. It is our responsibility to accurately classify, diagnose, and treat paroxysmal vertigo, including Meniere's disease. We have developed a recording device that can record nystagmus during attacks of vertigo in patients with paroxysmal vertigo at home, and by lending the device to the patients, we will obtain eye movement data during vertigo attacks and investigate the presence and direction of nystagmus during attacks as well as changes over time in its characteristics. In addition, since 2017, endolymphatic hydrops can be diagnosed by imaging with inner ear contrast-enhanced MRI, which has been adopted in Japan as a diagnostic criterion for Meniere's disease. These two results will be combined to accurately and correctly diagnose the condition of patients with paroxysmal vertigo and to provide appropriate treatment.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Evaluation of the presence or absence of abnormal eye movements, direction if any, and change over time (disappearance or opposite direction, etc.) in the video recorded by the eye movement recording device.

Key secondary outcomes

Evaluation of the eye movements during vertigo attack and the result of contrast-enhanced MRI

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

Observation with the equipment that is not approved

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

Age-lower limit

20

years-old

<=

Age-upper limit

90

years-old

>=

Gender

Male and Female

Key inclusion criteria

Patients with recurrent paroxysmal vertigo for whom a diagnosis cannot be made on general examination and who are able to operate an eye movement recording device

Key exclusion criteria

Pregnant or otherwise considered unsuitable by the Principal Investigator or Principal Investigator

Target sample size

100

Name of lead principal investigator

1st name	Kayoko
Middle name
Last name	Higashi-Shingai

Organization

OSAKA UNIVERSITY Graduate School of Medicine

Division name

Department of Otorhinolaryngology-Head and Neck Surgery

Zip code

565-0871

Address

2-2 Yamadaoka, Suita, Osaka JAPAN

TEL

+81-6-6879-3951

Email

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

Name of contact person

1st name	Kayoko
Middle name
Last name	Higashi-Shingai

Organization

OSAKA UNIVERSITY Graduate School of Medicine

Division name

Department of Otorhinolaryngology-Head and Neck Surgery

Zip code

565-0871

Address

2-2 Yamadaoka, Suita, Osaka JAPAN

TEL

09068793951

Homepage URL

Email

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

Institute

OSAKA UNIVERSITY

Institute

Department

Personal name

Organization

N/A

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Department of Otorhinolaryngology-Head and Neck Surgery OSAKA UNIVERSITY Graduate School of Medicine

Address

2-2 Yamadaoka,Suita Osaka JAPAN

Tel

0668793971

Email

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

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2024

Year

02

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

09

Month

30

Day

Date of IRB

Anticipated trial start date

2023

Year

10

Month

01

Day

Last follow-up date

2025

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2024

Year

02

Month

28

Day

Last modified on

2024

Year

02

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058913