UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016421 |
|---|---|
| Receipt number | R000019068 |
| Scientific Title | Randomized open-label controlled trial of Epley maneuver versus repeated Dix-Hallpike maneuver in patients with benign paroxysmal positional vertigo |
| Date of disclosure of the study information | 2015/02/04 |
| Last modified on | 2024/08/10 10:37:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized open-label controlled trial of Epley maneuver versus repeated Dix-Hallpike maneuver in patients with benign paroxysmal positional vertigo
Acronym
Epley maneuver versus repeated Dix-Hallpike maneuver in patients with BPPV
Scientific Title
Randomized open-label controlled trial of Epley maneuver versus repeated Dix-Hallpike maneuver in patients with benign paroxysmal positional vertigo
Scientific Title:Acronym
Epley maneuver versus repeated Dix-Hallpike maneuver in patients with BPPV
Region
| Japan |
Condition
Condition
benign paroxysmal positional vertigo
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison the success rate of Epley maneuver with that of repeated Dix-Hallpike maneuver in patients with benign paroxysmal positional vertigo
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The presence or absence of positioning nystagmus after one week
Key secondary outcomes
The presence of absence of positioning nystagmus just after Epley maneuver or repeated Dix-Hallpike maneuver
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
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 maneuver
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
patients with posterior canal type of benign paroxysmal positional vertigo
Key exclusion criteria
patients with cervical and/or lumber vertebra disease
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Takao |
| Middle name | |
| Last name | Imai |
Organization
Osaka University Graduate School of Medicine
Division name
Otorhinolaryngology - Head and Neck Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL
06-6879-3951
timai@ent.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Takao |
| Middle name | |
| Last name | Imai |
Organization
Osaka University Graduate School of Medicine
Division name
Otorhinolaryngology - Head and Neck Surgery
Zip code
565-0871
Address
2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL
06-6879-3951
Homepage URL
http://www.med.osaka-u.ac.jp/pub/ent/
timai@ent.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Otorhinolaryngology-Head & Neck Surgery, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kaken
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
Osaka University Clinical Research Review Committee
Address
Osaka University Clinical Research Review Committee, 2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan
Tel
0662108290
timai@ent.med.osaka-u.ac.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
大阪大学医学部附属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 04 | Day |
Related information
URL releasing protocol
http://www.med.osaka-u.ac.jp/pub/ent/index.html
Publication of results
Published
Result
URL related to results and publications
https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1095041/full
Number of participants that the trial has enrolled
203
Results
In a multicenter randomized controlled trial, the disappearance rate of positional nystagmus one week later was compared between a group in which positional nystagmus disappeared immediately due to benign paroxysmal positional vertigo fatigue and a group in which positional nystagmus disappeared using the Epley maneuver, and no difference was found between the two.
Results date posted
| 2024 | Year | 08 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Epley maneuver group Mean age 70.7years Male 24 Female 66
BPPV fatigue group Mean age 71.1years Male 26 Female 64
Participant flow
Patients diagnosed with posterior canal type of benign paroxysmal positional vertigo were divided into two groups of 90 patients each.
Adverse events
Nausea
Outcome measures
Rate of disappearance of positional nystagmus after one week
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2014 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 02 | Day |
Last modified on
| 2024 | Year | 08 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019068
