BPPVNCT03871413
TRV-chair vs Manual Repositioning Maneuver in Treatment of Benign Paroxysmal Positional Vertigo
A study testing TRV-chair and Manual repositioning maneuver in people with BPPV, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
Comparison of treatment efficacy of a mechanical rotational chair (TRV-chair) vs. manual repositioning maneuvers in BPPV Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BPPV
- What is being tested?
- TRV-chair and Manual repositioning maneuver
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2019to 1 Dec 2019
- 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
- Characteristic (for BPPV) positional nystagmus
- Positive Dix-Hallpike
- Positive supine roll test
- Medical history compatible with BPPV
Who cannot join
- Treatment in TRV-chair within the last 6 months
- Lack of treatment cooperation
- Known cerebral aneurism or cerebral hemorrhage
- Diagnosed and treated for BPPV within the past month
- Treatment with sedating anti-histamines within the past 7 days
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Otolaryngology, Head & Neck Surgery and Audiology
Aalborg, North Denmark, 9000
About this study
Official title: Can Benign Paroxysmal Positional Vertigo (BPPV) be Treated Faster and More Efficiently by Using a Mechanical Rotational Chair Compared to the Traditional Manual Repositioning Maneuvers?
Comparison of treatment efficacy of a mechanical rotational chair (TRV-chair) vs. manual repositioning maneuvers in BPPV
Read the detailed description
Open-label, randomized controlled trial comparing manual repositioning maneuvers with a mechanical rotational chair (TRV-chair) in diagnosing and treating BPPV. Patients with suspected BPPV will be randomized to either manual repositioning maneuvers or the TRV-chair.
- Conditions
- BPPV
- Being tested
- TRV-chair, Manual repositioning maneuver
- Keywords
- Benign Paroxysmal Positional Vertigo, Vertigo, Dizziness, Vestibular Diseases, Epley Maneuver, TRV-chair, Repositioning chair
- Medical subject headings
- Benign Paroxysmal Positional Vertigo, Vertigo, Dizziness, Vestibular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRV-chairDevice
Repositioning maneuvers in TRV-chair
Manual repositioning maneuverProcedure or surgery
Treatment with manual repositioning maneuver
| Study group | Role | What they receive |
|---|---|---|
| Manual repositioning maneuver | Active comparator | Diagnostics and treatment of BPPV with manual repositioning maneuvers. In case of posterior canal involvement, Epley's maneuver will be used. In case of horizontal canal involvement, the log roll maneuver will be used. Receives: Procedure: Manual repositioning maneuver |
| Treatment in mechanical rotational chair (TRV-chair) | Experimental | Diagnostics and treatment of BPPV with the use of a TRV chair. In case of posterior canal involvement, Epley's maneuver will be used with the addition of 10 kinetic impulses in each position.
In case of horizontal canal involvement, the log roll maneuver will be used with the addition of 10 kinetic impulses in each position. Receives: Device: TRV-chair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatments
Number of treatment necessary to achieve resolution of vertigo and nystagmus
Measured: 2 years
Treatment success after first treatment
Number of subjects achieving resolution of vertigo and nystagmus after one treatment
Measured: 2 years
Secondary outcomes (2)
Dizziness Handicap Inventory (DHI) questionnaire
Comparison of pre-treatment score and post-treatment score
Measured: 2 years
Adverse events
Registration of adverse events
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start1 Apr 2019
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPPVStudies of the same condition, open and under way.
- More trials run by Aalborg 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
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Dupont Hougaard, Aalborg University Hospital
- Investigators
- Dan D Hougaard, MD, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871413
- Sponsor's protocol ID
- TRV002
- Status last verified
- Jul 2020
- First submitted
- 8 Mar 2019
- Last updated
- 23 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Benign Paroxysmal Positional Vertigo (BPPV) be Treated Faster and More Efficiently by Using a Mechanical Rotational Chair Compared to the Traditional Manual Repositioning Maneuvers?
- ClinicalTrials.gov ID
- NCT03871413
- Acronym / sponsor ID
- TRV002
- Conditions
- BPPV
- Keywords
- Benign Paroxysmal Positional Vertigo, Vertigo, Dizziness, Vestibular Diseases, Epley Maneuver, TRV-chair, Repositioning chair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 12 Mar 2019 (actual)
- 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.
Comparison of treatment efficacy of a mechanical rotational chair (TRV-chair) vs. manual repositioning maneuvers in BPPV
Detailed description
Open-label, randomized controlled trial comparing manual repositioning maneuvers with a mechanical rotational chair (TRV-chair) in diagnosing and treating BPPV. Patients with suspected BPPV will be randomized to either manual repositioning maneuvers or the TRV-chair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual repositioning maneuver | Active comparator | Procedure: Manual repositioning maneuverDiagnostics and treatment of BPPV with manual repositioning maneuvers. In case of posterior canal involvement, Epley's maneuver will be used. In case of horizontal canal involvement, the log roll maneuver will be used. |
| Treatment in mechanical rotational chair (TRV-chair) | Experimental | Device: TRV-chairDiagnostics and treatment of BPPV with the use of a TRV chair. In case of posterior canal involvement, Epley's maneuver will be used with the addition of 10 kinetic impulses in each position. In case of horizontal canal involvement, the log roll maneuver will be used with the addition of 10 kinetic impulses in each position. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Characteristic (for BPPV) positional nystagmus
- Positive Dix-Hallpike
- Positive supine roll test
- Medical history compatible with BPPV
Key exclusion criteria (5 listed)
- Treatment in TRV-chair within the last 6 months
- Lack of treatment cooperation
- Known cerebral aneurism or cerebral hemorrhage
- Diagnosed and treated for BPPV within the past month
- Treatment with sedating anti-histamines within the past 7 days
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 |
|---|---|---|
| TRV-chairRepositioning maneuvers in TRV-chair | Device | Treatment in mechanical rotational chair (TRV-chair) |
| Manual repositioning maneuverTreatment with manual repositioning maneuver | Procedure or surgery | Manual repositioning maneuver |
Primary outcome
Number of treatments
Time frame: 2 years
Number of treatment necessary to achieve resolution of vertigo and nystagmus
Treatment success after first treatment
Time frame: 2 years
Number of subjects achieving resolution of vertigo and nystagmus after one treatment
2 secondary outcomes
Dizziness Handicap Inventory (DHI) questionnaire
Time frame: 2 years
Adverse events
Time frame: 2 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 23 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for BPPV
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.
Dan D Hougaard, MD principal investigator
Aalborg 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 TRV-chair and Manual repositioning maneuver in people with BPPV, run by Aalborg University Hospital at 1 site in Denmark.
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 5 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 23 Jul 2020. 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 Denmark. 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.
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?
Number of treatments (time frame: 2 years). The study lists 2 primary outcomes in all. 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 23 Jul 2020.