TRV-chair vs Manual Repositioning Maneuver in Treatment of Benign Paroxysmal Positional Vertigo

Study Overview
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Brief Summary
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Comparison of treatment efficacy of a mechanical rotational chair (TRV-chair) vs. manual repositioning maneuvers in BPPV

Detailed Description
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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.

Official Title
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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?

Conditions
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BPPV

Intervention / Treatment
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* Device: TRV-chair
* Procedure: Manual repositioning maneuver


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Characteristic (for BPPV) positional nystagmus Positive Dix-Hallpike Positive supine roll test Medical history compatible with BPPV Exclusion Criteria: Treatment in TRV-chair within the last 6 months Exclusion of BPPV diagnosis 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Manual repositioning maneuver<br>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. | Procedure: Manual repositioning maneuver<br>* Treatment with manual repositioning maneuver<br>|
| Experimental: Treatment in mechanical rotational chair (TRV-chair)<br>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. | Device: TRV-chair<br>* Repositioning maneuvers in TRV-chair<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of treatments | Number of treatment necessary to achieve resolution of vertigo and nystagmus | 2 years | 
| Treatment success after first treatment | Number of subjects achieving resolution of vertigo and nystagmus after one treatment | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dizziness Handicap Inventory (DHI) questionnaire | Comparison of pre-treatment score and post-treatment score | 2 years | 
| Adverse events | Registration of adverse events | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Benign Paroxysmal Positional Vertigo, Vertigo, Dizziness, Vestibular Diseases, Epley Maneuver, TRV-chair, Repositioning chair