UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057208 |
|---|---|
| Receipt number | R000065392 |
| Scientific Title | Analysis of eye movements before, during, and after vertigo attacks in patients with recurrent vertigo using a portable and wearable electronystagmography device |
| Date of disclosure of the study information | 2025/03/06 |
| Last modified on | 2025/03/04 22:50:36 |
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Basic information
Public title
Analysis of eye movements during vertigo attacks in patients with recurrent vertigo using a portable and wearable electronystagmography device
Acronym
Analysis of eye movements during vertigo attacks using a portable and wearable electronystagmography device
Scientific Title
Analysis of eye movements before, during, and after vertigo attacks in patients with recurrent vertigo using a portable and wearable electronystagmography device
Scientific Title:Acronym
Analysis of eye movements during vertigo attacks in patients with recurrent vertigo using a portable and wearable electronystagmography device
Region
| Japan |
Condition
Condition
Patients with recurrent vertigo
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine whether eye movements during vertigo recorded during sleep at home in patients with recurrent vertigo are helpful for early diagnosis of Meniere's disease and prediction of vertigo attacks. For the purpose, we developed a portable and wearable electronystagmography device to identify nystagmus during vertigo attacks. We also examine whether changes in nystagmus during vertigo attacks are correlated with the mechanism of the attack of Meniere's disease.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the direction, frequency, and maximum slow-phase eye velocity of nystagmus
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 |
Interventions/Control_1
Recording of eye movements during vertigo attacks in patients using a portable and wearable electronystagmography device to identify nystagmus
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 probable Meniere's disease who suffer from recurrent vertigo
Key exclusion criteria
1) Patients who cannot operate a portable and wearable electronystagmography device
2) Patients who are pregnant
3) Patients who are deemed inappropriate by the Principal Investigator or Co-Investigator
Target sample size
50
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
06-6879-3951
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
06-6879-3951
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
06-6879-3951
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
| 2025 | Year | 03 | Month | 06 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | 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
| 2025 | Year | 03 | Month | 04 | Day |
Last modified on
| 2025 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065392
