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Personalized Treatment of Refractory BPPV

RecruitingNAAges 18 Years - 100 YearsAllHospital Clinico Universitario de Santiago
NCT06725966 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Background: Benign paroxysmal positional vertigo (BPPV) is the most common cause of vertigo, often effectively treated with standard canalith repositioning maneuvers (CRMs). However, approximately 12.5% of cases remain refractory, leading to persistent symptoms and increased healthcare burden. Variations in the anatomical orientation of the semicircular canals (SCCs) may explain the resistance to conventional maneuvers. This study explores a personalized medicine approach, utilizing computational fluid dynamics (CFD) based on MRI reconstructions to tailor CRMs with the help of mechanical rotation chair according to individual inner ear anatomy. Methods: The investigators conducted a randomized, multicenter, open-label study targeting patients with refractory posterior canal BPPV. Participants were allocated to either a control group (receiving repeated standard CRMs and Brandt-Daroff ex

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📋 Eligibility rules (as published)
Inclusion Criteria: * A. Diagnosed with BPPVp according to the Barany Society criteria: 1. Recurrent episodes of vertigo or positional instability, triggered by lying down or turning the head in the supine position. 2. Episodes lasting less than 1 minute. 3. Positional nystagmus observed after a latency period during the Dix-Hallpike test (DHT), with an upward vertical component and a torsional component (clockwise on the left side and counterclockwise on the right). 4. Symptoms not explained by any other cause. AND * B. Refractory to otolith repositioning maneuvers (Epley and/or Semont maneuvers), with persistence of symptoms after three attempts. Exclusion Criteria: * Cognitive impairment that prevents understanding of their condition and the required procedures. * Pathological conditions that hinder the execution of the maneuvers. * BPPV involving canals other than the posterior canal or bilateral posterior canal involvement. * Low educational level, which may impede understanding of the procedures and informed consent.
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What it tests

  • Conventional Epley maneuver
  • Personalized Epley maneuver
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Where

1 site
Hospital Clínico Universitario
Santiago de Compostela, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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