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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025291
Receipt No. R000029081
Scientific Title Unblineded randomized test for determination of suitable operation time of Epley maneuver
Date of disclosure of the study information 2016/12/20
Last modified on 2018/04/08

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Basic information
Public title Unblineded randomized test for determination of suitable operation time of Epley maneuver
Acronym Determination of suitable operation time of Epley maneuver
Scientific Title Unblineded randomized test for determination of suitable operation time of Epley maneuver
Scientific Title:Acronym Determination of suitable operation time of Epley maneuver
Region
Japan

Condition
Condition benign paroxysmal positional vertigo
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of therapy effect
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the presence or absence of positional nystagmus after 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 Dose comparison
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 one minute position-maintaining time during Epley maneuver
Interventions/Control_2 three minutes position-maintaining time during Epley 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 benign paroxysmal positional vertigo
Key exclusion criteria patients with cervical and/or lumber vertebrae disease
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Imai
Organization Osaka University Graduate School of Medicine
Division name Otorhinolaryngology - Head and Neck Surgery
Zip code
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
Middle name
Last name Takao Imai
Organization Osaka University Graduate School of Medicine
Division name Otorhinolaryngology - Head and Neck Surgery
Zip code
Address 2-2 Yamadaoka, Suita-shi, Osaka 565-0871, Japan
TEL 06-6879-3951
Homepage URL
Email timai@ent.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2016 Year 12 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
2016 Year 12 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 15 Day
Last modified on
2018 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029081

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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