UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054208 |
|---|---|
| Receipt number | R000061848 |
| Scientific Title | Development of a new method to recovery positional nystagmus in posterior semicircular canal type benign paroxysmal positional vertigo that disappeared due to benign paroxysmal positional vertigo fatigue |
| Date of disclosure of the study information | 2024/04/20 |
| Last modified on | 2024/04/28 18:02:42 |
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Basic information
Public title
Development of a new method to recovery positional nystagmus in benign paroxysmal positional vertigo that disappeared due to benign paroxysmal positional vertigo fatigue
Acronym
Development of a new method to recovery positional nystagmus in benign paroxysmal positional vertigo
Scientific Title
Development of a new method to recovery positional nystagmus in posterior semicircular canal type benign paroxysmal positional vertigo that disappeared due to benign paroxysmal positional vertigo fatigue
Scientific Title:Acronym
Development of a new method to recovery benign paroxysmal positional nystagmus that disappeared due to BPPV fatigue
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
Posterior canal type of benign paroxysmal positional vertigo (BPPV) has a characteristic called BPPV fatigue in which when strong vertigo occurs, vertigo positional nystagmus are not induced for a while. The purpose of this study is to develop a method to eliminate the effects of BPPV fatigue.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The ratio of maximum slow phase eye velocity (MSPEV) of positional nystagmus when third Dix-Hallpike test against MSPEV of positional nystagmus when first Dix-Hallpike test
Key secondary outcomes
The values of all maximum slow phase eye velocity of positional nystagmus when first, second and third Dix-Hallpike tests
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
After confirming that BPPV fatigue has occurred in the second Dix-Hallpike test, in a sitting position, bend the head forward approximately 90 degrees and rotate it toward the affected side in 20 patients. In the other 10 patients, soon after confirming that BPPV fatigue has occurred in the second Dix-Hallpike test, the third Dix-Hallpike test will be performed.
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
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A case in which positional nystagmus typical of posterior canal type of benign paroxysmal positional vertigo is observed during the Dix-Hallpike test on the affected side.
Key exclusion criteria
Patients who have a disease in the neck or lumbar region and cannot undergo a Dix-Hallpike test
Pregnant woman
Other patients whose attending physician has determined that it is inappropriate to participate in this study
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Imai |
Organization
Bell Land 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
+81-72-234-2001
imaitakao@hotmail.com
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Imai |
Organization
Bell Land General Hospital
Division name
Clinical Research Review Board
Zip code
599-8247
Address
500-3 Higashi-yama, Naka-ku, Sakai-shi, Osaka, Japan
TEL
+81-72-234-2001
Homepage URL
irb@bh.seichokai.or.jp
Sponsor or person
Institute
Bell land General Hospital
Institute
Department
Personal name
Funding Source
Organization
KAKENHI Grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bell Land General Hospital
Address
500-3 Higashi-yama, Naka-ku, Sakai-shi, Osaka, Japan
Tel
+81-72-234-2001
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
| 2024 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 11 | 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
| 2024 | Year | 04 | Month | 20 | Day |
Last modified on
| 2024 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061848
