Personalized Treatment of Refractory BPPV

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorHospital Clinico Universitario de Santiago

About this trial

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 exercises) or an intervention group (receiving personalized CRMs based on CFD simulations derived from MRI scans). The intervention group's maneuvers were executed using a mechanical rotational chair designed for precise angulation. Primary outcomes included resolution of nystagmus and vertigo symptoms, while secondary outcomes measured the reduction in healthcare visits and improved quality of life (Dizziness Handicap Inventory score).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Recurrent episodes of vertigo or positional instability, triggered by lying down or turning the head in the supine position.

Episodes lasting less than 1 minute.

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).

Symptoms not explained by any other cause.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional Epley maneuver

    Procedure/Surgery

    Epley maneuver using a mechanized chair

  • Personalized Epley maneuver

    Procedure/Surgery

    Personalized Epley maneuver, using a mechanized chair

Treatment groups

54 Participants
are divided into 2 treatment groups
Group A: Conventional Epley maneuverActive comparator 1 intervention
Group B: Personalized Epley maneuverExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of curation

Percentage of participants in whom, after the maneuvers, no nystagmus is observed in the Dix and Hallpike test

Time frame
6 months

Secondary outcomes

1

Rate of resolution of symptomatology

Percentage of participants who, after the maneuvers, do not report vertigo in the Dix and Hallpike test

Time frame
6 months
2

DHI score

DHI (Dizzines Handicap Inventory) score after the maneuvers, compared to the score at the time of inclusion

Time frame
6 months
3

Number of sessions

Number of maneuvers need to curation

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hospital Clinico Universitario de Santiago

Lead sponsor

Instituto de Salud Carlos III

Collaborator

European Union

Collaborator