Treatment of Posterior Benign Paroxysmal Positional Vertigo With Mechanical Rotational Chair.

Study Overview
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Brief Summary
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Comparison of treatment efficacy of Epley maneuver and 360 maneuver in a mechanical rotational chair (TRV chair) in patient with posterior benign paroxysmal positional vertigo (BPPV).

Detailed Description
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Open-label, randomized controlled trial comparing the Epley maneuver with the 360 maneuver using the TRV chair in both scenarios. Patients diagnosed with posterior BPPV will be randomized to receive treatment with either the Epley maneuver or the 360 maneuver.

Official Title
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Treatment of Posterior Benign Paroxysmal Positional Vertigo With Mechanical Rotational Chair: A Randomized Controlled Trial Comparing Epley and 360° Maneuvers.

Conditions
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Benign Paroxysmal Positional Vertigo, BPPV

Intervention / Treatment
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* Procedure: The Epley Maneuver
* Procedure: The 360 Degree Maneuver
* Device: Mechanical rotational chair


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above 18 years Confirmed unilateral p-BPPV (canalithiasis and cupulolithiasis) Understand written and spoken Danish Exclusion Criteria: Pregnancy Weight ≥ 150 kg and or Height ≥ 2m Not possible to attend follow-up visits Insufficient cooperation during diagnostic testing or treatment in the mechanical rotational chair Have received treatment for BPPV in a mechanical rotational chair within the last 6 months Sedative antihistamines are taken within the past 7 days Comorbidities: Heart failure (EF<40), known cerebral aneurysm, cerebrovascular events (<3 months), and dissection disease Spontaneous or gaze evoked nystagmus.

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: the Epley Maneuver<br>Treatment of BPPV with the Epley Maneuver in the TRV chair. No kinetic energy will be used. | Procedure: The Epley Maneuver<br>* 5 step procedure where the patient: Sits upright in a neutral position Rotate 45° towards the affected side around the yaw axis and then ro-tate 135° backward around the pitch axis Rotated 90° towards the unaffected side around the yaw axis Rotate a further 90° toward the unaffected side around the yaw axis Rotates back to an upright position with a 135° backward rotation around the pitch axis.<br>Device: Mechanical rotational chair<br>* TRV chair<br>|
| Active Comparator: the 360 Maneuver<br>Treatment of BPPV with the 360 Maneuver in the TRV chair. | Procedure: The 360 Degree Maneuver<br>* 5 step procedure where the patient: Sits upright in a neutral position Rotate 45° towards the affected side around the yaw axis and then ro-tate 135° backward around the pitch axis Rotate a further 90° backward around the pitch axis (total 225°) Rotate a further 90° backward around the pitch axis (total 315°) Rotate back to an upright position with an additional 45° backward rota-tion around the pitch axis (total 360°).<br>Device: Mechanical rotational chair<br>* TRV chair<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dizziness Handicap Inventory (DHI) Questionnaire | Comparison of pre-treatment score and post-treatment score | 2 year | 
| Adverse events | Registration of adverse events | 2 year | 
| Recurrence rate | Recurrence of BPPV 3 and 6 months after successful treatment. | 2 year | 

 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, Mechanical Rotational Chair