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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
  Purpose

The purpose of this study was to compare the immediate efficacies of each treatment maneuvers in treatment of apogeotropic horizontal canal benign paroxysmal positional vertigo (HC-BPPV).


Condition Intervention Phase
HC-BPPV
 Procedure: Gufoni maneuver
Procedure: Head-shaking maneuver
Procedure: sham maneuver
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Multicenter Study of Treatment of Horizontal Canal Benign Paroxysmal Positional Vertigo

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Chonbuk National University:

Primary Outcome Measures:
  • Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial [ Time Frame: one hour ] [ Designated as safety issue: No ]
    The immediate treatment response was determined by participating neurologists in each clinic without knowing the maneuver applied to each patient from 30 minutes to one hour after initial maneuver. The absence of both vertigo and nystagmus was required to determine a resolution.


Enrollment: 157
Study Start Date: January 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Gufoni maneuver
Gufoni maneuver for apogeotropic HC-BPPV
 Procedure: Gufoni maneuver
For Gufoni maneuver,16,18 the patient was quickly brought down to the side-lying position on the affected ear from the sitting position. After one minute in this position, the head of the patient was quickly turned 45O upward, so that the nose directed upward. Approximately 2 minutes later, the patient was returned to the upright position (Figure 2A).
Active Comparator: Headshaking maneuver
headshaking maneuver for apogeotropic HC BPPV
 Procedure: Head-shaking maneuver
For head-shaking maneuver,15 patients were brought into a sitting position. After pitching the head forward by approximately 30O, we moved the head sideways in a sinusoidal fashion at an approximate rate of 3 Hz for 15 seconds.
Sham Comparator: sham maneuver
sham maneuver for apogeotropic HC BPPV
 Procedure: sham maneuver
For the sham maneuver, patients quickly lied on the unaffected side, and returned to the sitting position after one minute.

Detailed Description:

A randomized prospective study of patients with HC-BPPV. Patients with apogeotropic type of HC-BPPV were randomized to one of each three treatment groups at their first clinic visit. These groups included the Gufoni maneuver, head-shaking maneuver, and sham group in apogeotropic HC-BPPV. Responsiveness of treatment maneuver was determined by positioning maneuver immediately after each treatment method based on resolves of vertigo and positional nystagmus.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a history of brief episodes of positional vertigo,
  • direction-changing horizontal nystagmus beating toward the uppermost (apogeotropic nystagmus) or undermost (geotropic nystagmus) ear in both the lateral head turning positions,
  • no spontaneous nystagmus during upright sitting position, and
  • absence of identifiable central nervous system disorders that could explain the positional vertigo and nystagmus.

Exclusion Criteria:

  • central positional nystagmus with identifiable CNS lesions that could explain the positional nystagmus
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00810641

Locations
Korea, Republic of
Chonbuk National University Hospital
Jeonju, Cholabuk-do, Korea, Republic of, 560-712
Seoul National University Bundang Hospital
Seongnam, Kyoungki-do, Korea, Republic of
Sponsors and Collaborators
Chonbuk National University
Seoul National University Bundang Hospital
  More Information

No publications provided by Chonbuk National University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by Chonbuk National University:
BPPV(benign paroxysmal positional vertigo)
HC-BPPV(BPPV involving the horizontal semicircular canal)
Nystagmus
Treatment outcome
Horizontal Canal Benign Paroxysmal Positional Vertigo

Additional relevant MeSH terms:
Vertigo
Dizziness
Vestibular Diseases
Labyrinth Diseases
Ear Diseases
 Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Sensation Disorders

ClinicalTrials.gov processed this record on June 18, 2013