UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062573 |
|---|---|
| Receipt number | R000070939 |
| Scientific Title | Development of a method to enhance positional nystagmus for improving the diagnostic accuracy of posterior-canal-type benign paroxysmal positional vertigo |
| Date of disclosure of the study information | 2026/08/20 |
| Last modified on | 2026/08/13 22:22:35 |
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Basic information
Public title
Development of a method to enhance positional nystagmus for improving the diagnostic accuracy of posterior-canal-type benign paroxysmal positional vertigo
Acronym
Development of a method to enhance positional nystagmus for improving the diagnostic accuracy of posterior-canal-type benign paroxysmal positional vertigo
Scientific Title
Development of a method to enhance positional nystagmus for improving the diagnostic accuracy of posterior-canal-type benign paroxysmal positional vertigo
Scientific Title:Acronym
Development of a positional nystagmus enhancement method for posterior-canal-type BPPV
Region
| Japan |
Condition
Condition
Posterior-canal-type of benign paroxysmal positional vertigo
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to verify, through a randomized controlled trial, that in patients with posterior canal type of benign paroxysmal positional vertigo, the characteristic fatigue phenomenon where the nystagmus elicited by the second Dix Hallpike test becomes weaker than that of the first can be suppressed by performing a maneuver that restores fatigued positional nystagmus immediately before the second test, thereby inducing stronger positional nystagmus compared with cases in which the maneuver is not performed.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The ratio of the maximum slow phase eye velocity of positional nystagmus during the second Dix Hallpike test to that during the first Dix Hallpike test
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
To perform a maneuver that restores positional nystagmus from the fatigue phenomenon after the first Dix Hallpike test
Interventions/Control_2
Not to perform a maneuver that restores positional nystagmus from the fatigue phenomenon after the first Dix Hallpike test
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
| 18 | years-old | <= |
Age-upper limit
| 95 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 to 95 years who present with vertigo as the chief complaint and are diagnosed with posterior canal BPPV
Key exclusion criteria
1. Patients with disorders of the cervical or lumbar spine that preclude positional nystagmus testing
2. Pregnant women
3. Patients whom the attending physician judges to be unsuitable for participation in this study
Target sample size
26
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
0722342001
imaitakao@hotmail.com
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Imai |
Organization
Bellland General Hospital
Division name
Clinical Research Review Board
Zip code
599-8247
Address
500-3 Higashi-yama, Naka-ku, Sakai-shi, Osaka, Japan
TEL
0722342001
Homepage URL
imaitakao@hotmail.com
Sponsor or person
Institute
Bellland General Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
0722342001
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 | 08 | Month | 20 | 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
| 2026 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | 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 | 08 | Month | 13 | Day |
Last modified on
| 2026 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070939
