Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

NCT00810641 | Completed Phase 3 Results DMC

• 1 other identifier: KONOS
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 2

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  one hour

Study Arms (3)

Gufoni maneuver

ACTIVE COMPARATOR

Gufoni maneuver for apogeotropic HC-BPPV

Procedure: Gufoni maneuver

Headshaking maneuver

ACTIVE COMPARATOR

headshaking maneuver for apogeotropic HC BPPV

Procedure: Head-shaking maneuver

sham maneuver

SHAM COMPARATOR

sham maneuver for apogeotropic HC BPPV

Procedure: sham maneuver

Interventions

Gufoni maneuver PROCEDURE

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).

Gufoni maneuver

Head-shaking maneuver PROCEDURE

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.

Headshaking maneuver

sham maneuver PROCEDURE

For the sham maneuver, patients quickly lied on the unaffected side, and returned to the sitting position after one minute.

sham maneuver

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• central positional nystagmus with identifiable CNS lesions that could explain the positional nystagmus

Sponsors & Collaborators

• Chonbuk National University: lead
• Seoul National University Bundang Hospital: collaborator

Study Sites (2)

Chonbuk National University Hospital

Jeonju, Cholabuk-do, 560-712, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, Kyoungki-do, South Korea

Location

Related Publications (1)

• 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.

  PMID: 22170885 DERIVED

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo; Nystagmus, Pathologic

Condition Hierarchy (Ancestors)

Vertigo; Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ocular Motility Disorders; Cranial Nerve Diseases; Eye Diseases

Limitations and Caveats

In this study, resolution of BPPV was determined using a telephone interview during the follow-ups after one week.

Results Point of Contact

• Title: Treatment of apogeotropic HC BPPV
• Organization: KONOS

ohsun@jbnu.ac.kr

82 10 5538 6565

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 18, 2008
• Study Start: January 1, 2009
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 27, 2011
• Results First Posted: June 27, 2011

Record last verified: 2011-05

Locations

KR (2)