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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035611
Receipt No. R000040571
Scientific Title The randomized clinical trial for determination the head position of that interval time does not need during Epley maneuver
Date of disclosure of the study information 2019/02/15
Last modified on 2019/03/08

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Basic information
Public title The randomized clinical trial for determination the head position of that interval time does not need during Epley maneuver
Acronym Interval time during Epley maneuver
Scientific Title The randomized clinical trial for determination the head position of that interval time does not need during Epley maneuver
Scientific Title:Acronym Interval time during 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 To find the head position of that interval time does not need during Epley maneuver
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 Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 The interval time of first head position during Epley maneuver sets to be 10 minutes.
Interventions/Control_2 The interval time of third head position during Epley maneuver sets to be 10 minutes.
Interventions/Control_3 The interval time of fourth head position during Epley maneuver sets to be 10 minutes.
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 who are strongly suspected to exhibit BPPV by medical interview.
Key exclusion criteria Patients who have lumber and/or cervical spine disease. The pregnant. Patients who can not be obtained their consent.
Target sample size 51

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
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
TEL 06-6879-3951
Homepage URL
Email timai@ent.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

Funding Source
Organization JSPS KAKENHI Grant
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Osaka University Graduate School of Medicine

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
2019 Year 02 Month 15 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
2019 Year 02 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 08 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
2019 Year 01 Month 21 Day
Last modified on
2019 Year 03 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040571

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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