UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060886 |
|---|---|
| Receipt number | R000069337 |
| Scientific Title | Benign paroxysmal positional vertigo fatigue of inhibitory positional nystagmus in posterior-canal-type benign paroxysmal positional vertigo |
| Date of disclosure of the study information | 2026/03/10 |
| Last modified on | 2026/03/10 14:07:29 |
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Basic information
Public title
Benign paroxysmal positional vertigo fatigue of inhibitory positional nystagmus in posterior-canal-type benign paroxysmal positional vertigo
Acronym
BPPV fatigue of inhibitory positional nystagmus in posterior-canal-type BPPV
Scientific Title
Benign paroxysmal positional vertigo fatigue of inhibitory positional nystagmus in posterior-canal-type benign paroxysmal positional vertigo
Scientific Title:Acronym
BPPV fatigue of inhibitory positional nystagmus in posterior-canal-type BPPV
Region
| Japan |
Condition
Condition
Posterior-canal-type benign paroxysmal positional vertigo
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Posterior-canal-type benign paroxysmal positional vertigo (BPPV) exhibits a phenomenon known as BPPV fatigue, in which dizziness or vertigo symptoms and positional nystagmus weaken or disappear when the patient repeatedly assumes a vertigo-inducing head position. During these provoking head positions, the posterior canal on the affected side is stimulated, and the observed positional nystagmus represents excitatory nystagmus. Therefore, BPPV fatigue occurs in excitatory positional nystagmus. Meanwhile, in posterior-canal-type BPPV, inhibitory positional nystagmus is also elicited due to inhibition of the posterior canal on the affected side; however, it remains unclear whether BPPV fatigue occurs in inhibitory positional nystagmus. The purpose of this study is to clarify this question.
Basic objectives2
Others
Basic objectives -Others
Assessment and collection of safety data for the Imai maneuver
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
In patients with posterior-canal-type benign paroxysmal positional vertigo, inhibitory nystagmus in the affected posterior canal is induced by bending the head forward and rotating it toward the affected side while in a sitting position (a procedure called the Imai maneuver). The primary outcome measure of this study was the ratio of the maximum slow-phase eye velocity of positional nystagmus recorded during the second Imai maneuver to that recorded during the first Imai maneuver.
Key secondary outcomes
How the maximum slow-phase velocity of positional nystagmus changes over three consecutive Imai maneuvers
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Patients will be randomly assigned to either Group A or Group B, and the following interventions will be performed.
Group A
The Imai maneuver will be performed first, followed by a second Imai maneuver. During the second maneuver, the patient will maintain the head-bent-forward and affected side rotated position until the positional nystagmus disappears or for up to 30 seconds. The patient will then return to the upright sitting position, after which the Dix Hallpike maneuver toward the affected side will be performed. After returning to the sitting position again, a third Imai maneuver will be performed, and the head bent forward and affected side rotated position will be maintained until the nystagmus disappears or for up to 30 seconds. After completion of these procedures, the study intervention for that patient will end, and standard clinical care for posterior canal type benign paroxysmal positional vertigo will be provided thereafter.
Interventions/Control_2
Group B
The Imai maneuver will be performed first, followed by the Dix Hallpike maneuver toward the affected side. After returning to the sitting position, a second Imai maneuver will be performed, and the head bent forward and affected side rotated position will be maintained until the positional nystagmus disappears or for up to 30 seconds. After completion of these procedures, the study intervention for that patient will end, and standard clinical care for posterior canal type benign paroxysmal positional vertigo will be provided thereafter.
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
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
kdlsk
Key exclusion criteria
dkld
Target sample size
22
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Imai |
Organization
Bellland General Hospital
Division name
Otorhinolaryngology - Head and Neck Surgery
Zip code
599-8247
Address
500-3 Higashi-yama, Naka-ku, Sakai-shi, Osaka, Japan
TEL
072-234-2001
timai@ent.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Imai |
Organization
Bellland General Hospital
Division name
Otorhinolaryngology - Head and Neck Surgery
Zip code
599-8247
Address
500-3 Higashi-yama, Naka-ku, Sakai-shi, Osaka, Japan
TEL
072-234-2001
Homepage URL
timai@ent.med.osaka-u.ac.jp
Sponsor or person
Institute
Bellland General Hospital
Institute
Department
Personal name
Funding Source
Organization
Bellland General Hospital
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
Bellland General Hospital
Address
500-3 Higashi-yama, Naka-ku, Sakai-shi, Osaka, Japan
Tel
072-234-2001
irb@bh.seichokai.or.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
| 2026 | Year | 03 | Month | 10 | 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
| 2026 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 10 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 03 | Month | 10 | Day |
Last modified on
| 2026 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069337
