search
Back to results

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

Primary Purpose

HC-BPPV

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gufoni maneuver
Head-shaking maneuver
sham maneuver
Sponsored by
Chonbuk National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HC-BPPV focused on measuring BPPV(benign paroxysmal positional vertigo), HC-BPPV(BPPV involving the horizontal semicircular canal), Nystagmus, Treatment outcome, Horizontal Canal Benign Paroxysmal Positional Vertigo

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chonbuk National University Hospital
  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Gufoni maneuver

Headshaking maneuver

sham maneuver

Arm Description

Gufoni maneuver for apogeotropic HC-BPPV

headshaking maneuver for apogeotropic HC BPPV

sham maneuver for apogeotropic HC BPPV

Outcomes

Primary Outcome Measures

Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial
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.

Secondary Outcome Measures

Full Information

First Posted
December 17, 2008
Last Updated
May 31, 2011
Sponsor
Chonbuk National University
Collaborators
Seoul National University Bundang Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00810641
Brief Title
Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo
Acronym
BPPV-HC
Official Title
Randomized Multicenter Study of Treatment of Horizontal Canal Benign Paroxysmal Positional Vertigo
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chonbuk National University
Collaborators
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HC-BPPV
Keywords
BPPV(benign paroxysmal positional vertigo), HC-BPPV(BPPV involving the horizontal semicircular canal), Nystagmus, Treatment outcome, Horizontal Canal Benign Paroxysmal Positional Vertigo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gufoni maneuver
Arm Type
Active Comparator
Arm Description
Gufoni maneuver for apogeotropic HC-BPPV
Arm Title
Headshaking maneuver
Arm Type
Active Comparator
Arm Description
headshaking maneuver for apogeotropic HC BPPV
Arm Title
sham maneuver
Arm Type
Sham Comparator
Arm Description
sham maneuver for apogeotropic HC BPPV
Intervention Type
Procedure
Intervention Name(s)
Gufoni maneuver
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Head-shaking maneuver
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
sham maneuver
Intervention Description
For the sham maneuver, patients quickly lied on the unaffected side, and returned to the sitting position after one minute.
Primary Outcome Measure Information:
Title
Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial
Description
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.
Time Frame
one hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Chonbuk National University Hospital
City
Jeonju
State/Province
Cholabuk-do
ZIP/Postal Code
560-712
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Kyoungki-do
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
22170885
Citation
Kim JS, Oh SY, Lee SH, Kang JH, Kim DU, Jeong SH, Choi KD, Moon IS, Kim BK, Oh HJ, Kim HJ. Randomized clinical trial for apogeotropic horizontal canal benign paroxysmal positional vertigo. Neurology. 2012 Jan 17;78(3):159-66. doi: 10.1212/WNL.0b013e31823fcd26. Epub 2011 Dec 14.
Results Reference
derived

Learn more about this trial

Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

We'll reach out to this number within 24 hrs