Benign Paroxysmal Positional VertigoPhase 3HC BPPVNCT01366430
Treatment of Geotropic Horizontal Canal Benign Paroxysmal Positional Vertigo
A Phase 3 study testing Gufoni and Barbecue in people with Benign Paroxysmal Positional Vertigo, run by Chonbuk National University at 3 sites in South Korea.
Trial summary
The purpose of this study was to compare the immediate efficacies of each treatment maneuvers in treatment of geotorpic horizontal canal benign paroxysmal positional vertigo (HC-BPPV). Read more about this study
- Who is it for?
- Ages 11 years and older
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo
- What is being tested?
- Gufoni and Barbecue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 3 sitesSouth Korea
- Study dates
- Jan 2009to Apr 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 11 years and older
- All sexes
- No healthy volunteers
- Child, 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) ear in both the lateral head turning positions,
- no spontaneous nystagmus during upright sitting position
- 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
3 sites in 1 country.
South Korea3 sites
Chonbuk National University Hospital
Jeonju, Cholabuk-do, 560-712
Chonnam National University Hospital
Kwangju, Cholanam-do
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
About this study
Official title: Treatment of Geotropic Horizontal Canal Benign Paroxysmal Positional Vertigo; Randomized Controlled Trial of Barbeque Rotation and Gufoni Maneuver
The purpose of this study was to compare the immediate efficacies of each treatment maneuvers in treatment of geotorpic horizontal canal benign paroxysmal positional vertigo (HC-BPPV).
Read the detailed description
A randomized prospective study of patients with HC-BPPV. Patients with geotropic type of HC-BPPV were randomized to one of each three treatment groups at their first clinic visit. These groups included the barbecue maneuver, Gufoni's maneuver, and sham group in geotropic 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
- Benign Paroxysmal Positional Vertigo
- Being tested
- Gufoni, Sham, Barbecue
- 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.
GufoniProcedure or surgery
For Gufoni maneuver, the patient was quickly brought down on the healthy side from the sitting position, and the head was then turned about 45 degree down, so that the nose was on the bed. After 2 minutes in this position, the patient was returned to the upright position.
ShamProcedure or surgery
The sham maneuver the opposite of the first step for barbecue rotation; lying down from sitting position for 30 seconds, and head turn 90degree to the affected side for 1 minute, and then sit up.
BarbecueProcedure or surgery
For barbecue rotation, the head was rotated rapidly 90degree while supine in the direction of the healthy ear, which was immediately followed by a truncal rotation of 90degree in the same direction to lie on the intact side. After 30-60 seconds when the induced nystagmus was dissipated, the patients were subjected to a further 90degree rotation of the head and trunk en block in the same direction to attain the nose-down position. After a further 30-60 seconds, the head was again turned in the same direction so that the affected ear was downward. Finally, after another 30-60s, the patient was brought to sitting position. Only one maneuver was performed per session.
| Study group | Role | What they receive |
|---|---|---|
| Gefoni manenuver | Active comparator | Gefoni manenuver for Geotropic HC-BPPV Receives: Procedure: Gufoni |
| sham maneuver | Active comparator | sham maneuver for geotropic HC-BPPV Receives: Procedure: Sham |
| barbecue maneuver | Active comparator | barbecue maneuver for geotropic HC-BPPV Receives: Procedure: Barbecue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate therapeutic effects for the treatment of geotropic HC-BPPV
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. When the patient still showed positioning nystagmus or vertigo, the patient received the previously applied maneuver again.
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 posted6 Jun 2011 (estimated)
- Study startJan 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 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
- NCT01366430
- Sponsor's protocol ID
- Treatment of HC BPPV
- Acronym
- HC BPPV
- Status last verified
- Jan 2009
- First submitted
- 31 May 2011
- Last updated
- 6 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Geotropic Horizontal Canal Benign Paroxysmal Positional Vertigo; Randomized Controlled Trial of Barbeque Rotation and Gufoni Maneuver
- ClinicalTrials.gov ID
- NCT01366430
- Acronym / sponsor ID
- HC BPPV / Treatment of HC BPPV
- Conditions
- Benign Paroxysmal Positional Vertigo
- 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
- 170 participants (actual)
- Lead sponsor
- Chonbuk National UniversityUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- Jan 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 6 Jun 2011 (estimated)
- Results
- Not posted in the source record
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 geotorpic horizontal canal benign paroxysmal positional vertigo (HC-BPPV).
Detailed description
A randomized prospective study of patients with HC-BPPV. Patients with geotropic type of HC-BPPV were randomized to one of each three treatment groups at their first clinic visit. These groups included the barbecue maneuver, Gufoni's maneuver, and sham group in geotropic 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 |
|---|---|---|
| Gefoni manenuver | Active comparator | Procedure: GufoniGefoni manenuver for Geotropic HC-BPPV |
| sham maneuver | Active comparator | Procedure: Shamsham maneuver for geotropic HC-BPPV |
| barbecue maneuver | Active comparator | Procedure: Barbecuebarbecue maneuver for geotropic HC-BPPV |
Who may qualify
- Ages
- 11 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- a history of brief episodes of positional vertigo, direction-changing horizontal nystagmus beating toward the uppermost (apogeotropic nystagmus) ear in both the lateral head turning positions,
- no spontaneous nystagmus during upright sitting position
- 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 |
|---|---|---|
| GufoniFor Gufoni maneuver, the patient was quickly brought down on the healthy side from the sitting position, and the head was then turned about 45 degree down, so that the nose was on the bed. After 2 minutes in this position, the patient was returned to the upright position. | Procedure or surgery | Gefoni manenuver |
| ShamThe sham maneuver the opposite of the first step for barbecue rotation; lying down from sitting position for 30 seconds, and head turn 90degree to the affected side for 1 minute, and then sit up. | Procedure or surgery | sham maneuver |
| BarbecueFor barbecue rotation, the head was rotated rapidly 90degree while supine in the direction of the healthy ear, which was immediately followed by a truncal rotation of 90degree in the same direction to lie on the intact side. After 30-60 seconds when the induced nystagmus was dissipated, the patients were subjected to a further 90degree rotation of the head and trunk en block in the same direction to attain the nose-down position. After a further 30-60 seconds, the head was again turned in the same direction so that the affected ear was downward. Finally, after another 30-60s, the patient was brought to sitting position. Only one maneuver was performed per session. | Procedure or surgery | barbecue maneuver |
Primary outcome
Immediate therapeutic effects for the treatment of geotropic HC-BPPV
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. When the patient still showed positioning nystagmus or vertigo, the patient received the previously applied maneuver again.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2011.
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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.
3 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 and Barbecue in people with Benign Paroxysmal Positional Vertigo, run by Chonbuk National University at 3 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 3 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 6 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 3 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Immediate therapeutic effects for the treatment of geotropic HC-BPPV (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2011.