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)

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

Study Overview

• Status: Completed
• Conditions: Benign Paroxysmal Positional Vertigo
• Intervention / Treatment: Device: Automated vertigo repositioning chair; Other: Canalith Reposition Maneuver

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Turkey
  • Sultangazi
    • Istanbul, Sultangazi, Turkey, 34265
      • Haseki Sultangazi Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Robotic Maneuvering System (RMS); 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.	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).; Dix-Hallpike (for posterior canal involvement); Supine roll (for horizontal canal involvement); (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).; Epley's and/or Semont's maneuver (for posterior canal involvement); Barbecue and/or Gufoni's maneuver (for horizontal canal involvement); 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 Names: Robotic Maneuvering System (RMS)
ACTIVE_COMPARATOR: 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.	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: Dix-Hallpike (for posterior canal involvement); 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: Epley's maneuver (for posterior canal involvement); 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.; Other Names: Manual Reposition Maneuver

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stratejik Yenilikci Girisimler Ltd.
• Collaborators: Haseki Sultangazi Teaching and Research Hospital, University of Health Sciences
• Investigators: Principal Investigator: Murat H Ozkul, M.D., StatejikYG

Publications and helpful links

General Publications

• Tan J, Yu D, Feng Y, Song Q, You J, Shi H, Yin S. Comparative study of the efficacy of the canalith repositioning procedure versus the vertigo treatment and rehabilitation chair. Acta Otolaryngol. 2014 Jul;134(7):704-8. doi: 10.3109/00016489.2014.899711. Epub 2014 May 7.
• Choung YH, Shin YR, Kahng H, Park K, Choi SJ. 'Bow and lean test' to determine the affected ear of horizontal canal benign paroxysmal positional vertigo. Laryngoscope. 2006 Oct;116(10):1776-81. doi: 10.1097/01.mlg.0000231291.44818.be.
• West N, Hansen S, Moller MN, Bloch SL, Klokker M. Repositioning chairs in benign paroxysmal positional vertigo: implications and clinical outcome. Eur Arch Otorhinolaryngol. 2016 Mar;273(3):573-80. doi: 10.1007/s00405-015-3583-z. Epub 2015 Mar 7.
• Bhattacharyya N, Baugh RF, Orvidas L, Barrs D, Bronston LJ, Cass S, Chalian AA, Desmond AL, Earll JM, Fife TD, Fuller DC, Judge JO, Mann NR, Rosenfeld RM, Schuring LT, Steiner RW, Whitney SL, Haidari J; American Academy of Otolaryngology-Head and Neck Surgery Foundation. Clinical practice guideline: benign paroxysmal positional vertigo. Otolaryngol Head Neck Surg. 2008 Nov;139(5 Suppl 4):S47-81. doi: 10.1016/j.otohns.2008.08.022.
• Pedersen MF, Eriksen HH, Kjaersgaard JB, Abrahamsen ER, Hougaard DD. Treatment of Benign Paroxysmal Positional Vertigo with the TRV Reposition Chair. J Int Adv Otol. 2020 Aug;16(2):176-182. doi: 10.5152/iao.2020.6320.
• Nakayama M, Epley JM. BPPV and variants: improved treatment results with automated, nystagmus-based repositioning. Otolaryngol Head Neck Surg. 2005 Jul;133(1):107-12. doi: 10.1016/j.otohns.2005.03.027.
• Richard-Vitton T, Seidermann L, Fraget P, Mouillet J, Astier P, Chays A. [Benign positional vertigo, an armchair for diagnosis and for treatment: description and significance]. Rev Laryngol Otol Rhinol (Bord). 2005;126(4):249-51. French.
• Yanik B, Kulcu DG, Kurtais Y, Boynukalin S, Kurtarah H, Gokmen D. The reliability and validity of the Vertigo Symptom Scale and the Vertigo Dizziness Imbalance Questionnaires in a Turkish patient population with benign paroxysmal positional vertigo. J Vestib Res. 2008;18(2-3):159-70.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2022
• Primary Completion (ACTUAL): April 12, 2022
• Study Completion (ACTUAL): April 23, 2022

Study Registration Dates

• First Submitted: April 23, 2022
• First Submitted That Met QC Criteria: April 23, 2022
• First Posted (ACTUAL): April 29, 2022

Study Record Updates

• Last Update Posted (ACTUAL): April 29, 2022
• Last Update Submitted That Met QC Criteria: April 23, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Robotic; Vertigo; Dizziness; Automated; Epley maneuver; Vestibular diseases; RMS chair; Reposition chair; Multi canal BPPV
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness
• Other Study ID Numbers: SYG-RMS-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No