UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053728 |
|---|---|
| Receipt number | R000058913 |
| 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 |
| Date of disclosure of the study information | 2024/02/28 |
| Last modified on | 2025/03/02 17:57:37 |
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Basic information
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
Condition
Patients with recurrent paroxysmal vertigo attacks.
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Assessment
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
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 |
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
Eligibility
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
Research contact person
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
kshingai@ent.med.osaka-u.ac.jp
Public contact
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
kshingai@ent.med.osaka-u.ac.jp
Sponsor or person
Institute
OSAKA UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Department of Otorhinolaryngology-Head and Neck Surgery OSAKA UNIVERSITY Graduate School of Medicine
Address
2-2 Yamadaoka,Suita Osaka JAPAN
Tel
0668793971
kshingai@ent.med.osaka-u.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 02 | Month | 28 | 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
None
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 17 | 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
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 28 | Day |
Last modified on
| 2025 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058913
