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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016421
Receipt No. 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 2021/03/22

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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
Email 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/
Email timai@ent.med.osaka-u.ac.jp

Sponsor
Institute Department of Otorhinolaryngology-Head & Neck Surgery, Osaka University Graduate School of Medicine
Institute
Department

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
Email 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 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
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
2021 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019068

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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