HC-BPPVPhase 3BPPV-HCNCT00810641
Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo
A Phase 3 study testing Gufoni maneuver and Head-shaking maneuver in people with HC-BPPV, run by Chonbuk National University at 2 sites in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HC-BPPV
- What is being tested?
- Gufoni maneuver and Head-shaking maneuver
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jan 2009to May 2011
- Phase
- Phase 3
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- central positional nystagmus with identifiable CNS lesions that could explain the positional nystagmus
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Chonbuk National University Hospital
Jeonju, Cholabuk-do, 560-712
Seoul National University Bundang Hospital
Seongnam, Kyoungki-do
About this study
Official title: Randomized Multicenter Study of Treatment of Horizontal Canal Benign Paroxysmal Positional Vertigo
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).
Read the 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.
- Conditions
- HC-BPPV
- Being tested
- Gufoni maneuver, Head-shaking maneuver, sham maneuver
- Keywords
- BPPV(benign paroxysmal positional vertigo), HC-BPPV(BPPV involving the horizontal semicircular canal), Nystagmus, Treatment outcome, Horizontal Canal Benign Paroxysmal Positional Vertigo
- Medical subject headings
- Benign Paroxysmal Positional Vertigo, Nystagmus, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gufoni maneuverProcedure or surgery
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).
Head-shaking maneuverProcedure or surgery
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.
sham maneuverProcedure or surgery
For the sham maneuver, patients quickly lied on the unaffected side, and returned to the sitting position after one minute.
| Study group | Role | What they receive |
|---|---|---|
| Gufoni maneuver | Active comparator | Gufoni maneuver for apogeotropic HC-BPPV Receives: Procedure: Gufoni maneuver |
| Headshaking maneuver | Active comparator | headshaking maneuver for apogeotropic HC BPPV Receives: Procedure: Head-shaking maneuver |
| sham maneuver | Sham comparator | sham maneuver for apogeotropic HC BPPV Receives: Procedure: sham maneuver |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionMay 2011
- Study completionMay 2011
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 HC-BPPVStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810641
- Sponsor's protocol ID
- KONOS
- Acronym
- BPPV-HC
- Status last verified
- May 2011
- First submitted
- 17 Dec 2008
- Last updated
- 27 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 22170885
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Study of Treatment of Horizontal Canal Benign Paroxysmal Positional Vertigo
- ClinicalTrials.gov ID
- NCT00810641
- Acronym / sponsor ID
- BPPV-HC / KONOS
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Chonbuk National UniversityUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- Jan 2009
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 18 Dec 2008 (estimated)
- Results
- Posted 27 Jun 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gufoni maneuver | Active comparator | Procedure: Gufoni maneuverGufoni maneuver for apogeotropic HC-BPPV |
| Headshaking maneuver | Active comparator | Procedure: Head-shaking maneuverheadshaking maneuver for apogeotropic HC BPPV |
| sham maneuver | Sham comparator | Procedure: sham maneuversham maneuver for apogeotropic HC BPPV |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- central positional nystagmus with identifiable CNS lesions that could explain the positional nystagmus
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 maneuverFor 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). | Procedure or surgery | Gufoni maneuver |
| Head-shaking maneuverFor 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. | Procedure or surgery | Headshaking maneuver |
| sham maneuverFor the sham maneuver, patients quickly lied on the unaffected side, and returned to the sitting position after one minute. | Procedure or surgery | sham maneuver |
Primary outcome
Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial
Time frame: one hour
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22170885Kim 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.
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gufoni maneuver and Head-shaking maneuver in people with HC-BPPV, run by Chonbuk National University at 2 sites 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 4 inclusion and 1 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 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 27 Jun 2011). 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?
Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo: A Randomized Clinical Trial (time frame: one hour). 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 NCT00810641, 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 27 Jun 2011.