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

Phase 1

Completed

• Conditions: Benign Paroxysmal Positional Vertigo
• Interventions: Other: Canalith Reposition Maneuver; Device: Automated vertigo repositioning chair

• Registration Number: NCT05352555
• Lead Sponsor: Stratejik Yenilikci Girisimler Ltd.

Brief 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.

Study Timeline

• Study Start: 2022-02-15
• Status Verified: 2022-04
• Primary Completion: 2022-04-12
• Study Completion: 2022-04-23
• Study First Submitted: 2022-04-23
• Study First Submitted QC: 2022-04-23
• Last Update Submitted: 2022-04-23
• Study First Posted: 2022-04-29
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Canalith Reposition Maneuver	Canalith Reposition Maneuver	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.
Robotic Maneuvering System (RMS)	Automated vertigo repositioning chair	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.

Primary Outcome Measures

Name	Time	Method
Treatment success	After treatment: 1 week - 1 month (30 days)	Number of subjects achieving resolution of vertigo and nystagmus after one treatment
Number of Treatments	1 month (30 days)	Number of treatment necessary to achieve resolution of vertigo and nystagmus

Secondary Outcome Measures

Name	Time	Method
Vertigo-Dizziness Imbalance (VDI) questionnaire	1 month (30 days)	Comparison of pre-treatment and post-treatment score based on symptoms and quality of life
Adverse events	1 month (30 days)	Registration of adverse events and safety issues related to RMS.

Trial Locations

Locations (1)

Haseki Sultangazi Training and Research Hospital; 🇹🇷 Istanbul, Sultangazi, Turkey