NCT02046980

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
209

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
8 months until next milestone

Results Posted

Study results publicly available

March 11, 2016

Completed
Last Updated

March 11, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

January 25, 2014

Results QC Date

December 4, 2015

Last Update Submit

February 12, 2016

Conditions

Benign Paroxysmal Positional Vertigo

Outcome Measures

Primary Outcomes (1)

  • Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus

    2 days

Study Arms (3)

Gufoni

EXPERIMENTAL

Gufoni maneuver for apogeotropic horizontal BPPV at the first day

Procedure: Gufoni

Vibration

EXPERIMENTAL

Vibration maneuver for apogeotropic horizontal BPPV at the first day

Procedure: Vibration

Sham

SHAM COMPARATOR

Sham maneuver for apogeotropic horizontal BPPV at the first day

Procedure: Sham

Interventions

GufoniPROCEDURE
Gufoni
VibrationPROCEDURE
Vibration
ShamPROCEDURE
Sham

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • history of vertigo associated with changes in head position
  • 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
  • vertigo associated with the elicited nystagmus
  • symptom within 2 weeks
  • put one's signature on consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Daegu Kyungbook Dizziness society

Daegu, South Korea

Location

Related Publications (1)

  • Kim HA, Park SW, Kim J, Kang BG, Lee J, Han BI, Seok JI, Chung EJ, Kim J, Lee H. Efficacy of mastoid oscillation and the Gufoni maneuver for treating apogeotropic horizontal benign positional vertigo: a randomized controlled study. J Neurol. 2017 May;264(5):848-855. doi: 10.1007/s00415-017-8422-2. Epub 2017 Feb 20.

    PMID: 28220291DERIVED

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo

Interventions

Vibrationsalicylhydroxamic acid

Condition Hierarchy (Ancestors)

VertigoVestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mechanical PhenomenaPhysical Phenomena

Results Point of Contact

Title
Dr. Hyun Ah Kim
Organization
Daegu Kyungbook Dizziness society
kha0206@dsmc.or.kr
+82-53-250-7475

Study Officials

  • Hyun Ah Kim

    Daegu KyungBook Dizziness society

    STUDY DIRECTOR

  • Hyung Lee

    Keimyung University Dongsan Medical Centerl

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 25, 2014

First Posted

January 28, 2014

Study Start

September 1, 2013

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

March 11, 2016

Results First Posted

March 11, 2016

Record last verified: 2016-02

Locations

KR(1)