Efficacy of a New Type of Mechanical Rotational Chair in Treating BPPV

Study Overview
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Brief Summary
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A study to establish the efficacy of a new type of mechanical rotational chair in treating BPPV. In addition, comparison of three types of treatment maneuvers using the mechanical rotational chair.

Detailed Description
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Open-label, randomized controlled trial comparing three different treatment maneuvers in a mechanical rotational chair (ROTUNDUM-chair) in treating BPPV. Patients diagnosed with BPPV will be randomized to one of three maneuvers in the ROTUNDUM-chair: Epley's maneuver Semont maneuver 360 degree vertical rotation

Official Title
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Efficacy of a New Type of Mechanical Rotational Chair (ROTUNDUM) in Treating BPPV

Conditions
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BPPV

Intervention / Treatment
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* Procedure: Epley's Maneuver
* Procedure: Semont Maneuver
* Procedure: 360 degree vertical rotation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Characteristic (for BPPV) positional nystagmus Positive Dix-Hallpike Test Medical history compatible with BPPV Exclusion Criteria: Treatment in a mechanical rotational chair within the last 6 months Exclusion of BPPV diagnosis Lack of treatment cooperation Known cerebral aneurism or cerebral hemorrhage Treated for BPPV within the past month

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: Epley's Maneuver<br>Treatment of posterior canal BPPV with Epley's maneuver in the ROTUNDUM-chair. | Procedure: Epley's Maneuver<br>* Treatment with Epley's Maneuver in the ROTUNDUM-chair<br>|
| Experimental: Semont Maneuver<br>Treatment of posterior canal BPPV with the Semont maneuver in the ROTUNDUM-chair. | Procedure: Semont Maneuver<br>* Treatment with the Semont Maneuver in the ROTUNDUM-chair<br>|
| Active Comparator: 360 degree vertical rotation<br>Treatment of posterior canal BPPV with a 360 degree vertical rotation in the ROTUNDUM-chair. | Procedure: 360 degree vertical rotation<br>* Treatment with 360 degree vertical rotation in the ROTUNDUM-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 treatments 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- and post-treatment score, total score between 0 and 100. Higher score reflects worse condition | 2 years | 
| Adverse events | Registration of adverse events | 2 years | 
| Value of liberatory nystagmus | Registration of liberatory nystagmus after each treatment as a prognostic factor for treatment success | 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, Semont Maneuver, Repositioning chair