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Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo (BPPV-HC)

This study has been completed.
Sponsor:
Collaborator:
Seoul National University Bundang Hospital
Information provided by:
Chonbuk National University
ClinicalTrials.gov Identifier:
NCT00810641
First received: December 17, 2008
Last updated: May 31, 2011
Last verified: May 2011
History of Changes
Results First Received: May 25, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: HC-BPPV
Interventions: Procedure: Gufoni maneuver
Procedure: Head-shaking maneuver
Procedure: sham maneuver

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between February 2009 and October 2009, consecutive patients with a diagnosis of apogeotropic HC-BPPV were recruited from nationwide 10 Dizziness Clinics in Korea.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
We defined the transition as a conversion into another canal type of BPPV without intervening periods of remission. In contrast, recurrence was defined as a redevelopment of any type of BPPV after a confirmed resolution of the positioning nystagmus and vertigo.

Reporting Groups
  Description
Gufoni Maneuver Gufoni maneuver for apogeotropic HC-BPPV
Headshaking Maneuver headshaking maneuver for apogeotropic HC BPPV
Sham Maneuver sham maneuver for apogeotropci HC BPPV

Participant Flow:   Overall Study
    Gufoni Maneuver     Headshaking Maneuver     Sham Maneuver  
STARTED     52     54     51  
COMPLETED     52     53     49  
NOT COMPLETED     0     1     2  
Withdrawal by Subject                 0                 1                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Gufoni Maneuver Gufoni maneuver for apogeotropic HC-BPPV
Headshaking Maneuver headshaking maneuver for apogeotropic HC BPPV
Sham Maneuver sham maneuver for apogeotropci HC BPPV
Total Total of all reporting groups

Baseline Measures
    Gufoni Maneuver     Headshaking Maneuver     Sham Maneuver     Total  
Number of Participants  
[units: participants]
 		  52     54     51     157  
Age  
[units: participants]
 		       
<=18 years     1     0     0     1  
Between 18 and 65 years     32     30     27     89  
>=65 years     19     24     24     67  
Age  
[units: years]
Mean ± Standard Deviation 		  57.8  ± 13.5     60.5  ± 12.4     61.5  ± 14.9     59.9  ± 13.6  
Gender  
[units: participants]
 		       
Female     39     30     28     97  
Male     13     24     23     60  
Region of Enrollment  
[units: participants]
 		       
Korea, Republic of     52     54     51     157  



  Outcome Measures

1.  Primary:   Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial   [ Time Frame: one hour ]
  Show Outcome Measure 1


  Serious Adverse Events
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Reporting Groups
  Description
Gufoni Maneuver Gufoni maneuver for apogeotropic HC-BPPV
Headshaking Maneuver headshaking maneuver for apogeotropic HC BPPV
Sham Maneuver sham maneuver for apogeotropci HC BPPV

Serious Adverse Events
    Gufoni Maneuver     Headshaking Maneuver     Sham Maneuver  
Total, serious adverse events        
# participants affected / at risk     0/0 (0.00%)     0/0 (0.00%)     0/0 (0.00%)  




  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
In this study, resolution of BPPV was determined using a telephone interview during the follow-ups after one week.  


Results Point of Contact:  
Name/Title: Treatment of apogeotropic HC BPPV
Organization: KONOS
phone: 82 10 5538 6565
e-mail: ohsun@jbnu.ac.kr


No publications provided by Chonbuk National University

Publications automatically indexed to this study:


Responsible Party: KONOS, Korean neuro-ophthalmology and neuro-otology society
ClinicalTrials.gov Identifier: NCT00810641     History of Changes
Other Study ID Numbers: KONOS
Study First Received: December 17, 2008
Results First Received: May 25, 2011
Last Updated: May 31, 2011
Health Authority: Korea: Food and Drug Administration