UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009321 |
|---|---|
| Receipt number | 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 16:27:32 |
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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
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
timai@ent.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Otorhinolaryngology - Head and Neck Surgery, Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010943
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
