UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047649 |
|---|---|
| Receipt number | R000054309 |
| Scientific Title | The development of simple canalith repositioning procedure for the treatment of posterior canal type of benign paroxysmal positional vertigo |
| Date of disclosure of the study information | 2022/11/29 |
| Last modified on | 2024/11/07 16:20:33 |
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Basic information
Public title
The development of simple canalith repositioning procedure for the treatment of posterior canal type of benign paroxysmal positional vertigo
Acronym
The development of simple treatment of benign paroxysmal positional vertigo
Scientific Title
The development of simple canalith repositioning procedure for the treatment of posterior canal type of benign paroxysmal positional vertigo
Scientific Title:Acronym
The development of simple canalith repositioning procedure for the treatment of posterior canal type of benign paroxysmal positional vertigo
Region
| Japan |
Condition
Condition
benign paroxysmal positional vertigo
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To show that the immediate effect of Epley maneuver is BPPV fatigue itself
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
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Epley maneuver
Interventions/Control_2
Repeated 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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patient with posterior canal type of benign paroxysmal positional vertigo
Key exclusion criteria
Patients who did not consent to participate in this study
Patients with medical history or possibility of cervical or lumber disease
Patients with severe heart disease
Patients with possible pregnancy, and pregnant women
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Imai |
Organization
Bell Land General Hospital
Division name
Center for dizziness and hearing loss treatment
Zip code
5998247
Address
500-3 Higashiyama, Naka-ku, Sakai-shi, Osaka 5998247, Japan
TEL
072-234-2001
t_imai@seichokai.or.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Imai |
Organization
Bell Land General Hospital
Division name
Center for dizziness and hearing loss treatment
Zip code
5998247
Address
500-3 Higashiyama, Naka-ku, Sakai-shi, Osaka 5998247, Japan
TEL
072-234-2001
Homepage URL
t_imai@seichokai.or.jp
Sponsor or person
Institute
Center for dizziness and hearing loss treatment
Bell Land General Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
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
Research ethics committee, Bell Land General Hospital
Address
500-3 Higashiyama, Naka-ku, Sakai-shi, Osaka 5998247, 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
ベルランド総合病院 （大阪府）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 11 | Month | 29 | 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
| 2022 | Year | 04 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 04 | Month | 28 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2023 | 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
| 2022 | Year | 05 | Month | 04 | Day |
Last modified on
| 2024 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054309
