Benign Paroxysmal Positional VertigoPhase 2NCT02046980

Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo

A Phase 2 study testing Gufoni and Vibration in people with Benign Paroxysmal Positional Vertigo, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 19 to 80 years
Conditions the study is for: Benign Paroxysmal Positional Vertigo
What is being tested?: Gufoni and Vibration
Type of treatment: Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 209 participants
Where: 1 siteSouth Korea
Study dates: Sep 2013to Jul 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

Daegu Kyungbook Dizziness society
Daegu

Other trials in South Korea

About this study

Read the 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.

Conditions: Benign Paroxysmal Positional Vertigo
Being tested: Gufoni, Vibration, Sham
Medical subject headings: Benign Paroxysmal Positional Vertigo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GufoniProcedure or surgery
VibrationProcedure or surgery
ShamProcedure or surgery

Study groups in NCT02046980
Study group	Role	What they receive
Gufoni	Experimental	Gufoni maneuver for apogeotropic horizontal BPPV at the first day Receives: Procedure: Gufoni
Vibration	Experimental	Vibration maneuver for apogeotropic horizontal BPPV at the first day Receives: Procedure: Vibration
Sham	Sham comparator	Sham maneuver for apogeotropic horizontal BPPV at the first day Receives: Procedure: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus
Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Jul 2015

First posted28 Jan 2014 (estimated)
Study startSep 2013
Primary completionJul 2015
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Benign Paroxysmal Positional VertigoStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 209 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02046980
Sponsor's protocol ID: DK-0001
Status last verified: Feb 2016
First submitted: 25 Jan 2014
Last updated: 11 Mar 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 28220291

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effectiveness of Epley Maneuver Versus Semont Maneuver on Dizziness and Balance in Stroke Survivors With Posterior Canal BPPV
Stroke
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Epley Versus Semont-plus Maneuver for Benign Paroxysmal Positional Vertigo
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Enrolling by invitationObservational study
Comparison of Two Mechanical Rotation Chairs With Diagnostics of Benign Paroxysmal Positional Vertigo.
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Not yet recruiting
The Effect of Chewing Gum on Dizziness in Patients Diagnosed With Posterior Canal Benign Paroxysmal Positional Vertigo in the Emergency Department
Vertigo Benign Positional, Dizziness
Active, not recruiting
Benign Paroxysmal Positional Vertigo With and Without Vestibular Hypofunction: Protocol for an Integrated Home-Based Exercise With Self-Managed Education Programme
Benign Paroxysmal Positional Vertigo (BPPV), Vestibular Hypofunction

All Benign Paroxysmal Positional Vertigo trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo
ClinicalTrials.gov ID: NCT02046980
Acronym / sponsor ID: DK-0001
Conditions: Benign Paroxysmal Positional Vertigo
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 209 participants (actual)
Lead sponsor: Keimyung University Dongsan Medical CenterUniversity, hospital or other
Study start: Sep 2013
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 28 Jan 2014 (estimated)
Results: Posted 11 Mar 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Gufoni	Experimental	Procedure: GufoniGufoni maneuver for apogeotropic horizontal BPPV at the first day
Vibration	Experimental	Procedure: VibrationVibration maneuver for apogeotropic horizontal BPPV at the first day
Sham	Sham comparator	Procedure: ShamSham maneuver for apogeotropic horizontal BPPV at the first day

Who may qualify

Ages: 19 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Gufoni	Procedure or surgery	Gufoni
Vibration	Procedure or surgery	Vibration
Sham	Procedure or surgery	Sham

Primary outcome

Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus
Time frame: 2 days

Results and safety

Results posted to the registry on 11 Mar 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gufoni	72	70
Vibration	72	67
Sham	73	72

Primary outcome: Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus

Time frame: 2 days. Number. Unit: participants

Measure	Gufoni n = 70	Vibration n = 67	Sham n = 72
Value	51	46	38

Gufoni vs Sham: Odds Ratio (OR): 3.39 (95% CI 1.58 to 7.31), p = 0.02839, Regression, Logistic
Vibration vs Sham: Odds Ratio (OR): 2.67 (95% CI 1.25 to 5.67), p = 0.0366, Regression, Logistic

Population analysed: 217 patients enrolled in the study but 8 retracted their agreements.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gufoni	0 of 72 (0%)	0 of 72 (0%)	Not reported
Vibration	0 of 72 (0%)	0 of 72 (0%)	Not reported
Sham	0 of 73 (0%)	0 of 73 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28220291Kim 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.

Related trials for Benign Paroxysmal Positional Vertigo

Recruiting
Effectiveness of Epley Maneuver Versus Semont Maneuver on Dizziness and Balance in Stroke Survivors With Posterior Canal BPPV
Stroke
Not yet recruiting
Epley Versus Semont-plus Maneuver for Benign Paroxysmal Positional Vertigo
Benign Paroxysmal Positional Vertigo (BPPV)
Enrolling by invitationObservational study
Comparison of Two Mechanical Rotation Chairs With Diagnostics of Benign Paroxysmal Positional Vertigo.
Benign Paroxysmal Positional Vertigo (BPPV)
Not yet recruiting
The Effect of Chewing Gum on Dizziness in Patients Diagnosed With Posterior Canal Benign Paroxysmal Positional Vertigo in the Emergency Department
Vertigo Benign Positional, Dizziness
Active, not recruiting
Benign Paroxysmal Positional Vertigo With and Without Vestibular Hypofunction: Protocol for an Integrated Home-Based Exercise With Self-Managed Education Programme
Benign Paroxysmal Positional Vertigo (BPPV), Vestibular Hypofunction

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hyun Ah Kim study director

Daegu KyungBook Dizziness society

Hyung Lee study chair

Keimyung University Dongsan Medical Centerl

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Gufoni and Vibration in people with Benign Paroxysmal Positional Vertigo, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Conversion in Direction of Nystagmus From Apogeotropic to Geotropic or Disappearance of Nystagmus (time frame: 2 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02046980, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2016.