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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009321
Receipt No. R000010943
Scientific Title Investigating the most effective head trace in performing benign paroxysmal positional vertigo diagnostic maneuver
Date of disclosure of the study information 2012/11/13
Last modified on 2019/05/19

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Basic information
Public title Investigating the most effective head trace in performing benign paroxysmal positional vertigo diagnostic maneuver
Acronym Investigating BPPV diagnostic maneuver
Scientific Title Investigating the most effective head trace in performing benign paroxysmal positional vertigo diagnostic maneuver
Scientific Title:Acronym Investigating BPPV diagnostic maneuver
Region
Japan

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

Objectives
Narrative objectives1 To investigate the most effective head trace in performing BPPV diagnostic maneuver
Basic objectives2 Others
Basic objectives -Others To investigate new BPPV diagnostic maneuver
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes check the presence of benign paroxysmal positional nystagmus
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 We repeat usual positional and positioning nystagmus test several times. And during the test, we change from usual head angle to the head angle that is decided in this trial.
Interventions/Control_2
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
3 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria patients suspected with benign paroxysmal positional vertigo by medical interview
Key exclusion criteria patents with trouble in their neck and/or waist
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Takao
Middle name
Last name Imai
Organization Osaka University Graduate School of Mecine
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 Mecine
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
Email timai@ent.med.osaka-u.ac.jp

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

Funding Source
Organization Japan society for the promotion of science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Osaka University Hospital
Address 2-15 Yamadaoka, Suita-shi, Osaka 565-0871, Japan
Tel 06-6879-5685
Email rinri@hp-crc.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 大阪大学医学部付属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 13 Day

Related information
URL releasing protocol http://www.med.osaka-u.ac.jp/pub/hp-crc/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
2012 Year 11 Month 08 Day
Date of IRB
2012 Year 11 Month 08 Day
Anticipated trial start date
2012 Year 11 Month 13 Day
Last follow-up date
2020 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
2012 Year 11 Month 12 Day
Last modified on
2019 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010943

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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