UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056602 |
|---|---|
| Receipt number | R000064688 |
| Scientific Title | Comparison of positional nystagmus with and without a method to restore positional nystagmus from benign paroxysmal positional vertigo fatigue immediately after the Epley maneuver |
| Date of disclosure of the study information | 2025/01/06 |
| Last modified on | 2025/07/01 12:17:10 |
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Basic information
Public title
Comparison of positional nystagmus with and without a maneuver to restore positional nystagmus from benign paroxysmal positional vertigo fatigue immediately after the Epley maneuver
Acronym
Positional nystagmus after the Epley maneuver when performing the maneuver to restore positional nystagmus from BPPV fatigue
Scientific Title
Comparison of positional nystagmus with and without a method to restore positional nystagmus from benign paroxysmal positional vertigo fatigue immediately after the Epley maneuver
Scientific Title:Acronym
Positional nystagmus after the Epley maneuver when performing the maneuver to restore positional nystagmus from 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
The purpose of this study is to compare the strength of positional nystagmus in patients with posterior canal type of benign paroxysmal positional vertigo who underwent a maneuver to restore from benign paroxysmal positional vertigo fatigue after the Epley maneuver with that in those who did not.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Maximum slow phase eye velocity of positional nystagmus after the Epley maneuver
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
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
After the Epley maneuver, a maneuver is performed to restore positional nystagmus due to benign paroxysmal positional fatigue.
Interventions/Control_2
After the Epley maneuver, a maneuver is not performed to restore positional nystagmus due to benign paroxysmal positional fatigue.
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
Outpatients (20-95 years old) at our hospital whose complaint was dizziness and/or vertigo and whose B score was 2 or more than 2.
Key exclusion criteria
Patients who did not consent to participate, had a medical history or possibility of cervical or lumber disease, had severe heart disease, or were possibly pregnant, and pregnant women.
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
0722342001
imaitakao@hotmail.com
Public contact
Name of contact person
| 1st name | Sayaka |
| Middle name | |
| Last name | Yasuda |
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
0722342001
Homepage URL
irb@bh.seichokai.or.jp
Sponsor or person
Institute
Department of Otorhinolaryngology - Head and Neck Surgery, Bell Land General Hospital Takao Imai
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI Grant
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
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
| 2025 | Year | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 06 | 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 | 12 | Month | 29 | Day |
Last modified on
| 2025 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064688
