Benign Paroxysmal Positional VertigoNCT01905800
BPPV Treatment in Biaxial Rotational Chair
A study testing Biaxial rotational chair in people with Benign Paroxysmal Positional Vertigo, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
Benign paroxysmal positional vertigo (BPPV) represents the most common cause of labyrinthine vertigo with a lifetime prevalence of 2.4 percent. Onset is most common between the fifth and seventh decades of life. The disease can be a major handicap for the affected patient, and causes a great expense for society. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Benign Paroxysmal Positional Vertigo
- What is being tested?
- Biaxial rotational chair
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2013to Jul 2017
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects over 18 years with benign paroxysmal positional vertigo(BPPV)
Who cannot join
- BPPV previously treated with reposition maneuvers within the last 12 months.
- Cochlear Implant (CI).
- Asymmetrical hearing loss.
- Unusual headache.
- Neurological disease.
- Inner ear disease other than BPPV.
Show all 17Show fewer
- Semicircular canal paresis.
- Drug that causes dizziness/nystagmus.
- Chemotherapy.
- Hospital admission due to head trauma within the last 12 months.
- Closeness to study group.
- Downbeating nystagmus or upbeating nystagmus without torsional component.
- Extensive spontaneous nystagmus that complicates gait interpretation.
- Cannot tolerate both treatments.
- Pregnancy.
- Bilateral affection of the semicircular canals.
- More than two semicircular canals affected on one side.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Multicenter Study of Benign Paroxysmal Positional Vertigo Treatment in Biaxial Rotational Chair
Benign paroxysmal positional vertigo (BPPV) represents the most common cause of labyrinthine vertigo with a lifetime prevalence of 2.4 percent. Onset is most common between the fifth and seventh decades of life. The disease can be a major handicap for the affected patient, and causes a great expense for society. The traditional manual treatment with repositioning maneuvers has greatly improved the possibilities for treatment of BPPV the last decade. However some patients are still difficult to diagnose and treat, and there are some who for health reasons cannot undergo traditional manual treatment. In this perspective there is a demand for a reliable, effective and precise method to treat all semicircular canals for the differentiated patient groups, and the techniques are under continuous development.
Read the detailed description
There has been extended research to improve the techniques and develop better and more reliable methods for diagnosing and treating BPPV efficiently. An important part in this technique evolution is the development of biaxial rotational chairs that can treat the patients regardless of other health problems.
Mechanical assistance chairs have been designed to diagnose, differentiate and treat more precisely all forms of positional vertigo. The patient is strapped to a chair and fitted with infrared video goggles which identify and quantify the nystagmus in different positions. Dr. John M. Epley developed the Epley Omniax System, an automated, power driven, multi axial patient positioning device that can move the patient into any position to treat the affected canal. This chair is electronically managed. Another mechanical assistance chair, the TRV chair, developed by Thomas Richard-Vitton in Marseille France, became commercially available in 2005. This chair has a vertical and a horizontal axis of rotation and is lockable in preset positions. It is manually handled and can swivel between two axes in all planes of the semicircular canals for up to 360 degrees or more. Velocity of rotation can be regulated freely.
The TRV chair is used by 34 centers worldwide today. Bergen (Norway) was the first place in North-Europe to acquire this chair, and have used it since December 2009. In 2013 Rigshospitalet Denmark started using the TRV chair as well and Oslo University Hospital Rikshospitalet, will have their chair in 2013. The TRV chair opens for treatment that previously was not possible.
The aim of this study is to:
- Evaluate the presence of positional nystagmus in the normal population
- Evaluate the efficacy of D-BBC treatment compared to S-BBC for treatment of lateral canal BPPV in TRV chair
- Examine the serum level of vitamin D in BPPV patients
- Give a detailed description of the method.
- Conditions
- Benign Paroxysmal Positional Vertigo
- Being tested
- Biaxial rotational chair
- Keywords
- Vertigo and dizziness., semicircular canals
- Medical subject headings
- Benign Paroxysmal Positional Vertigo, Vertigo, Dizziness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biaxial rotational chairDevice
Also called TRV chair
This chair has a vertical and a horizontal axis of rotation and is lockable in preset positions. It is manually handled and can swivel between two axes in all planes of the semicircular canals for up to 360 degrees or more. Velocity of rotation can be regulated freely.
| Study group | Role | What they receive |
|---|---|---|
| Barbecue treatment without acceleration | Active comparator | Treatment of horizontal BPPV with adapted maneuvers using a biaxial rotational chair and infrared videoscopy goggle. The patient is positioned in supine position and rotated 30 degrees stepwise towards the unaffected ear, thus applying an overall 360 degrees rotation. The patient remains in each position for 30 seconds Receives: Device: Biaxial rotational chair |
| Barbecue treatment with acceleartion | Experimental | Treatment of horizontal BPPV with adapted maneuvers using a biaxial rotational chair and infrared videoscopy goggle. The patient starts in supine position and will be rotated about a horizontal axis from head to feet. The patient will be rotated 360 degrees with a succession of eight fast rounds in the axial plane towards the unaffected side. Receives: Device: Biaxial rotational chair |
| Placebo treatment | Placebo comparator | Positional examination of horizontal BPPV with adapted maneuvers using a biaxial rotational chair and infrared videoscopy goggle. The patient is positioned in supine position and rotated 30 degrees stepwise towards the unaffected ear, thus applying a rotation towards the other side. Receives: Device: Biaxial rotational chair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of change in velocity in treatment of lateral canal BPPV
Two week cure rate
Measured: Four years
Secondary outcomes (1)
Effect of change in velocity in treatment of lateral canal BPPV
Difference in dynamic barbecue and stepwise barbecue three months after treatment (Cure rate and DHI)
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilla Martens, Haukeland University Hospital
- Investigators
- Camilla Martens, MD, Principal investigator, Haukeland University HospitalStein Helge Nordahl Glad, Study director, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01905800
- Sponsor's protocol ID
- 2013/980
- Status last verified
- Nov 2018
- First submitted
- 15 Jul 2013
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: We do not plan to make individual participant data (IPD) available
Publications
Martens C, Goplen FK, Aasen T, Gjestad R, Nordfalk KF, Nordahl SHG. Treatment of horizontal canal BPPV-a randomized sham-controlled trial comparing two therapeutic maneuvers of different speeds. Laryngoscope Investig Otolaryngol. 2020 Jun 29;5(4):750-757. doi: 10.1002/lio2.420. eCollection 2020 Aug.
PubMed 32864448
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Multicenter Study of Benign Paroxysmal Positional Vertigo Treatment in Biaxial Rotational Chair
- ClinicalTrials.gov ID
- NCT01905800
- Acronym / sponsor ID
- 2013/980
- Conditions
- Benign Paroxysmal Positional Vertigo
- Keywords
- Vertigo and dizziness., semicircular canals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 23 Jul 2013 (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.
Benign paroxysmal positional vertigo (BPPV) represents the most common cause of labyrinthine vertigo with a lifetime prevalence of 2.4 percent. Onset is most common between the fifth and seventh decades of life. The disease can be a major handicap for the affected patient, and causes a great expense for society. The traditional manual treatment with repositioning maneuvers has greatly improved the possibilities for treatment of BPPV the last decade. However some patients are still difficult to diagnose and treat, and there are some who for health reasons cannot undergo traditional manual treatment. In this perspective there is a demand for a reliable, effective and precise method to treat all semicircular canals for the differentiated patient groups, and the techniques are under continuous development.
Detailed description
There has been extended research to improve the techniques and develop better and more reliable methods for diagnosing and treating BPPV efficiently. An important part in this technique evolution is the development of biaxial rotational chairs that can treat the patients regardless of other health problems.
Mechanical assistance chairs have been designed to diagnose, differentiate and treat more precisely all forms of positional vertigo. The patient is strapped to a chair and fitted with infrared video goggles which identify and quantify the nystagmus in different positions. Dr. John M. Epley developed the Epley Omniax System, an automated, power driven, multi axial patient positioning device that can move the patient into any position to treat the affected canal. This chair is electronically managed. Another mechanical assistance chair, the TRV chair, developed by Thomas Richard-Vitton in Marseille France, became commercially available in 2005. This chair has a vertical and a horizontal axis of rotation and is lockable in preset positions. It is manually handled and can swivel between two axes in all planes of the semicircular canals for up to 360 degrees or more. Velocity of rotation can be regulated freely.
The TRV chair is used by 34 centers worldwide today. Bergen (Norway) was the first place in North-Europe to acquire this chair, and have used it since December 2009. In 2013 Rigshospitalet Denmark started using the TRV chair as well and Oslo University Hospital Rikshospitalet, will have their chair in 2013. The TRV chair opens for treatment that previously was not possible.
The aim of this study is to:
- Evaluate the presence of positional nystagmus in the normal population
- Evaluate the efficacy of D-BBC treatment compared to S-BBC for treatment of lateral canal BPPV in TRV chair
- Examine the serum level of vitamin D in BPPV patients
- Give a detailed description of the method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Barbecue treatment without acceleration | Active comparator | Device: Biaxial rotational chairTreatment of horizontal BPPV with adapted maneuvers using a biaxial rotational chair and infrared videoscopy goggle. The patient is positioned in supine position and rotated 30 degrees stepwise towards the unaffected ear, thus applying an overall 360 degrees rotation. The patient remains in each position for 30 seconds |
| Barbecue treatment with acceleartion | Experimental | Device: Biaxial rotational chairTreatment of horizontal BPPV with adapted maneuvers using a biaxial rotational chair and infrared videoscopy goggle. The patient starts in supine position and will be rotated about a horizontal axis from head to feet. The patient will be rotated 360 degrees with a succession of eight fast rounds in the axial plane towards the unaffected side. |
| Placebo treatment | Placebo comparator | Device: Biaxial rotational chairPositional examination of horizontal BPPV with adapted maneuvers using a biaxial rotational chair and infrared videoscopy goggle. The patient is positioned in supine position and rotated 30 degrees stepwise towards the unaffected ear, thus applying a rotation towards the other side. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjects over 18 years with benign paroxysmal positional vertigo(BPPV)
Key exclusion criteria (17 listed)
- BPPV previously treated with reposition maneuvers within the last 12 months.
- Cochlear Implant (CI).
- Asymmetrical hearing loss.
- Unusual headache.
- Neurological disease.
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 |
|---|---|---|
| Biaxial rotational chairAlso: TRV chairThis chair has a vertical and a horizontal axis of rotation and is lockable in preset positions. It is manually handled and can swivel between two axes in all planes of the semicircular canals for up to 360 degrees or more. Velocity of rotation can be regulated freely. | Device | Barbecue treatment with acceleartion, Barbecue treatment without acceleration, Placebo treatment |
Primary outcome
Effect of change in velocity in treatment of lateral canal BPPV
Time frame: Four years
Two week cure rate
1 secondary outcome
Effect of change in velocity in treatment of lateral canal BPPV
Time frame: Four years
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 14 Nov 2018.
- Derived from this study: PubMed 32864448Martens C, Goplen FK, Aasen T, Gjestad R, Nordfalk KF, Nordahl SHG. Treatment of horizontal canal BPPV-a randomized sham-controlled trial comparing two therapeutic maneuvers of different speeds. Laryngoscope Investig Otolaryngol. 2020 Jun 29;5(4):750-757. doi: 10.1002/lio2.420. eCollection 2020 Aug.
- Individual participant dataSharing planned: No. We do not plan to make individual participant data (IPD) available
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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.
Camilla Martens, MD principal investigator
Haukeland University Hospital
Stein Helge Nordahl Glad study director
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biaxial rotational chair in people with Benign Paroxysmal Positional Vertigo, run by Haukeland University Hospital at 1 site in Norway.
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 1 inclusion and 17 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 14 Nov 2018. 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 Norway. 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.
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?
Effect of change in velocity in treatment of lateral canal BPPV (time frame: Four years). 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 NCT01905800, 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 14 Nov 2018.