NCT05352555

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

Comparison of Treatment Efficacy of Automated Robotic Maneuvering System (RMS) Reposition Chair Versus Traditional Manual Repositioning Maneuvers in Benign Paroxysmal Positional Vertigo (BPPV)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Stratejik Yenilikci Girisimler Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Benign Paroxysmal Positional Vertigo

Interventions

Type	Name	Description
DEVICE	Automated vertigo repositioning chair	Patients are strapped to the chair with a safety harness, and video fenzel goggle are worn. Automated diagnostic procedures are performed to determine vertigo subtype and orientation (Left/Right) (described below). 1. Dix-Hallpike (for posterior canal involvement) 2. Supine roll (for horizontal canal involvement) 3. (Optional) Deep Head Hanging (for anterior canal involvement) If nystagmus is detected during automated diagnostic maneuvers, BPPV subtype is diagnosed, and corresponding automated treatment maneuver will be performed (described below). 1. Epley's and/or Semont's maneuver (for posterior canal involvement) 2. Barbecue and/or Gufoni's maneuver (for horizontal canal involvement) 3. Yacovino's maneuver (for anterior canal involvement) 10 minutes after performing automated treatment maneuver, provocative diagnostic test maneuver was performed once again to ensure successful intervention. A follow-up was done one week later at the earliest.
OTHER	Canalith Reposition Maneuver	Patients were seated on a examination table and given videonystagmography goggles (VNG). Manual diagnostic procedures are performed to determine vertigo subtype and orientation. The manual diagnostic procedures for Left and Right sided semicircular canals are: 1. Dix-Hallpike (for posterior canal involvement) 2. Supine roll and Bow and Lean (for horizontal canal involvement) If nystagmus is detected during diagnostic maneuvers, BPPV subtype is diagnosed, and corresponding treatment maneuvers will be performed manually. The automated treatment maneuvers are: 1. Epley's maneuver (for posterior canal involvement) 2. Barbecue and/or Gufoni's maneuver (for horizontal canal involvement) Patients were called back for a follow up 2 days after performing manual treatment maneuvers. Provocative diagnostic testing maneuvers were performed again to ensure successful intervention. A second follow-up was done one week later at the earliest.

Timeline

• Start date: 2022-02-15
• Primary completion: 2022-04-12
• Completion: 2022-04-23
• First posted: 2022-04-29
• Last updated: 2022-04-29

Locations

1 site across 1 country: Turkey (Türkiye)