UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041573
Receipt number R000047462
Scientific Title Study on new test method for dizziness diagnosis
Date of disclosure of the study information 2020/08/27
Last modified on 2023/02/28 09:40:39

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Basic information

Public title

Study on new test method for dizziness diagnosis

Acronym

Study on new test method for dizziness diagnosis

Scientific Title

Study on new test method for dizziness diagnosis

Scientific Title:Acronym

Study on new test method for dizziness diagnosis

Region

Japan


Condition

Condition

Balance disorder

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To explore the usefulness of LBT and RNG for the diagnosis of dizziness. In addition to the conventional evaluation methods, LBT and RNG are evaluated and analyzed with dizziness symptoms and vestibular function test results.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Measurements of LBT and RNG (mean, standard deviation, R score, RNG score, RNG 2 score, FODs, Ac score) and center of gravity sway test (total locus length, velocity Romberg rate (rubber), closed eye rubber ratio (velocity), (Gravichart type), Caloric test (maximum slow phase velocity, CP%), cVEMP (p13-n23 amplitude), oVEMP (n1-p1 amplitude), DHI, SDS, GDS, HADS correlation coefficient or ratio

Key secondary outcomes

Measurements of LBT and RNG (mean, standard deviation, R score, RNG score, RNG 2 score, FODs, Ac score) and age, gender, diagnosis, dominant hand, dominant eye, hearing test (standard pure tone hearing test, inner ear function Examination, gaze nystagmus, head nystagmus, head position change nystagmus, stepping test, spontaneous nystagmus, follow-up test, two-point alternating gaze test, correlation coefficient or correlation with visual motor nystagmus (OKN) ratio


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

Prevention

Type of intervention

Behavior,custom Maneuver

Interventions/Control_1

(1) Line segment bisecting task
Perform the test with the application software installed on the computer.
1) Place the examinee's chin on a chin stand 60 cm away from the LCD monitor to fix the face position.
2) Ask the subject to see the cross-shaped figure displayed in the center of the LCD monitor and adjust the position so that the eye level and the center are aligned.
3) Make the examination room dark.
4) Explain to the subject that the quadrangle displayed on the LCD monitor is halved in horizontal length regardless of the shape of the figure. Regarding the operation, the vertical line segment is moved by moving the mouse, and the position is determined by left-clicking. The quadrangle is a rectangle and is rotated 0degrees, 15degrees, 30degrees, 45degrees, 60degrees, 75degrees, 105degrees, 120degrees, 135degrees, 150degrees, 165degrees to the right around the long side bisector. 11 patterns are displayed. The vertical line segments are displayed from the upper left, lower left, upper right, and lower right outside the figure from the four patterns. Test a total of 44 squares with 11 patterns and 4 vertical line segment display positions. No specific explanation will be given to the subjects.
5) Conduct 4 exercises and start the test if there are no questions.
6) Measure the time taken for the test.
7) Confirm and record the dominant hand and dominant eye.
The average and standard deviation of the deviation from the center of the division position is calculated for each of the 11 types of figures.
(2) Random number generation task
1) Randomly tell the inspector a number from 1 to 9 as quickly as possible.
2) First, practice for 15 seconds, and then do the final test for 2 minutes.
3) Record the vocal data with an IC recorder and transfer the data to a computer for storage.
4) After the inspection, the inspector writes down the data. The utterances that do not match the conditions are saved as blank.
5) Use a separate explanation sheet.

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 Those who are 20 years of age or older at the time of obtaining consent
2 Any gender
3 It does not matter if you have a hearing loss
4 Those who, after receiving a sufficient explanation before participating in this study, have a sufficient understanding and consent of the study subject themselves.

Key exclusion criteria

1 Person with visual impairment
2 Those who have difficulty operating a computer
3 In addition, those who the research director has determined to be inappropriate as a research target

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Shinichi
Middle name
Last name Ishimoto

Organization

JR Tokyo General Hospital

Division name

Otolaryngology

Zip code

151-8528

Address

2-1-3 Yoyogi, Shibuya-ku, Tokyo

TEL

03-3320-2210

Email

shinchan-tky@umin.ac.jp


Public contact

Name of contact person

1st name Teru
Middle name
Last name Kamogashira

Organization

2-1-3 Yoyogi, Shibuya-ku, Tokyo

Division name

Otolaryngology

Zip code

151-8528

Address

2-1-3 Yoyogi, Shibuya-ku, Tokyo

TEL

03-3320-2210

Homepage URL


Email

tkamogashira-tky@umin.ac.jp


Sponsor or person

Institute

JR Tokyo General Hospital
Otolaryngology

Institute

Department

Personal name



Funding Source

Organization

Self-procurement

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

JR Tokyo General Hospital

Address

2-1-3 Yoyogi, Shibuya-ku, Tokyo

Tel

03-3320-2210

Email

06share09@jreast.co.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



Other administrative information

Date of disclosure of the study information

2020 Year 08 Month 27 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

100

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

2020 Year 08 Month 01 Day

Date of IRB

2020 Year 07 Month 29 Day

Anticipated trial start date

2020 Year 08 Month 01 Day

Last follow-up date

2022 Year 08 Month 31 Day

Date of closure to data entry

2022 Year 08 Month 31 Day

Date trial data considered complete

2022 Year 08 Month 31 Day

Date analysis concluded

2024 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2020 Year 08 Month 27 Day

Last modified on

2023 Year 02 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047462


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name