Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

February 12, 2016 updated by: HyunAh Kim, Keimyung University Dongsan Medical Center
To determine the short term therapeutic efficacies of Gufoni maneuver and mastoid oscillation in apogeotropic type of benign paroxysmal positional vertigo (BPPV) involving the horizontal semicircular canal (HC-BPPV), a randomized, prospective, sham-controlled study was conducted.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The apogeotropic type of benign paroxysmal positional vertigo involving the horizontal canal (HC-BPPV) is likely due to otolithic debris in the anterior arm of the canal (canalithiasis) or the debris attached to the cupula (cupulolithiasis). It is important to seek the method to convert treatment-resistant apogeotropic form to the more treatment-responsive geotropic form in HC-BPPV. Recent randomized trials demonstrated that head shaking maneuver was more effective than the modified Semont maneuver and the Gufoni and head shaking maneuvers showed similar efficacy in treating apogeotropic HC-BPPV. Moreover, new repositioning maneuver using mastoid vibration showed good efficacies in patients with apogeotropic HC-BPPV in recent study. So we tried to compare the short term therapeutic efficacies of Gufoni maneuver and mastoid oscillation in apogeotropic HC-BPPV with a randomized, prospective, sham-controlled study.

Study Type

Interventional

Enrollment (Actual)

209

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. history of vertigo associated with changes in head position
  2. direction-changing horizontal nystagmus beating toward the uppermost ear (apogeotropic nystagmus) in both turning positions detected with Frenzel glasses or videoculography in the Head turning test
  3. vertigo associated with the elicited nystagmus
  4. symptom within 2 weeks
  5. put one's signature on consent

Exclusion Criteria:

  1. patients with identifiable central nervous system disorders that could explain the positional vertigo and nystagmus
  2. the patients with apogeotropic form which was transited from geotropic after previous therapeutic maneuvers
  3. the patients who transited from apogeotropic from vertical canal BPPV during study
  4. patients who had possible cause of secondary BPPV such as Meniere's disease, migraine or recent trauma history
  5. patients whose affected ear cannot be identified
  6. patients with multiple canal atypical positional nystagmus or who were treated previously with repositioning maneuvers were excluded.
  7. patients with cervical or lumbar spine problem

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gufoni
Gufoni maneuver for apogeotropic horizontal BPPV at the first day
Procedure: Gufoni
Experimental: Vibration
Vibration maneuver for apogeotropic horizontal BPPV at the first day
Procedure: Vibration
Sham Comparator: Sham
Sham maneuver for apogeotropic horizontal BPPV at the first day
Procedure: Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus
Time Frame: 2 days
2 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Keimyung University Dongsan Medical Center

Investigators

  • Study Director: Hyun Ah Kim, Daegu Kyungbook Dizziness society
  • Study Chair: Hyung Lee, Keimyung University Dongsan Medical Centerl

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

January 25, 2014

First Submitted That Met QC Criteria

January 25, 2014

First Posted (Estimate)

January 28, 2014

Study Record Updates

Last Update Posted (Estimate)

March 11, 2016

Last Update Submitted That Met QC Criteria

February 12, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK-0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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