Automated Robotic Maneuvering System (RMS) vs Manual Reposition Maneuver in Treatment of Benign Paroxysmal Positional Vertigo (BPPV)

Stratejik Yenilikci Girisimler

Status and phase: Completed; Phase 2; Phase 1

Conditions: Benign Paroxysmal Positional Vertigo

Treatments: Device: Automated vertigo repositioning chair; Other: Canalith Reposition Maneuver

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05352555

SYG-RMS-18

Details and patient eligibility

About

Comparison of treatment efficacy of an automated robotic maneuvering system (RMS) repositioning chair versus manual positioning maneuvers in Benign Paroxysmal Positional Vertigo.

Full description

The standard treatments for Benign Paroxysmal Positional Vertigo (BPPV) are manual positioning maneuvers. This method, beyond being costly and requiring extensive training, is a significant burden on healthcare resources. We developed an automated robotic maneuvering system, hereby known as RMS, to tackle this problem. Our Clinical Investigation is two-fold; (1) test the safety of RMS and, (2) understand the viability of RMS for treating BPPV when compared to manual positioning maneuvers.

Enrollment: 75 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Characteristic positional nystagmus (for BPPV)
• Positive Dix-Hallpike
• Positive supine roll test
• Positive Deep Head Hanging
• Vertigo-Dizziness Imbalance symptom scores compatible with BPPV

Exclusion criteria

• Pregnant patients
• Patients who have taken vertigo suppressing agents (Dimenhydrinate) in the last 48 hours
• Patients taller than 200 cm (2.0 m)
• Patients who have had a cardiovascular or neurosurgical operation in the last month
• Patients with retinal detachment and/or glaucoma
• Lack of treatment cooperation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups

Robotic Maneuvering System (RMS)

Experimental group

Description:

BPPV subtype diagnosis and corresponding treatment will be performed using automated RMS chair and recorded with video frenzel goggle. In cases of posterior canal involvement, Epley's maneuver will be used for canalithiasis and cupulolithiasis. Semont maneuver will be used as a second-line treatment for cupulolithiasis, in cases of initial failure. In cases of horizontal canal involvement, Barbecue (Lempert) maneuver will be used. If canalithiasis or cupulolithiasis is diagnosed, Gufoni's maneuver will be performed. In cases of anterior canal involvement, Yacovino's maneuver will be used.

Treatment:

Device: Automated vertigo repositioning chair

Canalith Reposition Maneuver

Active Comparator group

Description:

BPPV subtype diagnosis and corresponding treatment will be performed with manual repositioning maneuvers and recorded with video frenzel goggle. In cases of posterior canal involvement, Epley's maneuver will be used. In cases of horizontal canal involvement, Log roll maneuver will be used. In cases of anterior canal involvement, Yacovino's maneuver will be used.

Treatment:

Other: Canalith Reposition Maneuver