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

NCT05352555 | Completed Phase 1 DMC

• 1 other identifier: SYG-RMS-18
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Benign Paroxysmal Positional Vertigo

Keywords

Automated; Robotic; Vertigo; Epley maneuver; RMS chair; Reposition chair; Dizziness; Vestibular diseases; Multi canal BPPV

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Vertigo-Dizziness Imbalance (VDI) questionnaire

  1 month (30 days)

• Adverse events

  1 month (30 days)

Study Arms (2)

Robotic Maneuvering System (RMS)

EXPERIMENTAL

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

Canalith Reposition Maneuver

ACTIVE COMPARATOR

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

Interventions

Automated vertigo repositioning chair DEVICE

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.

Also known as: Robotic Maneuvering System (RMS)

Robotic Maneuvering System (RMS)

Canalith Reposition Maneuver OTHER

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.

Also known as: Manual Reposition Maneuver

Canalith Reposition Maneuver

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stratejik Yenilikci Girisimler Ltd.: lead
• Haseki Sultangazi Teaching and Research Hospital, University of Health Sciences: collaborator

Study Sites (1)

Haseki Sultangazi Training and Research Hospital

Istanbul, Sultangazi, 34265, Turkey (Türkiye)

Location

Related Publications (8)

• 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.

  PMID: 24807849 BACKGROUND

• 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.

  PMID: 17003735 BACKGROUND

• 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.

  PMID: 25749489 BACKGROUND

• 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.

  PMID: 18973840 BACKGROUND

• 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.

  PMID: 32784154 BACKGROUND

• 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.

  PMID: 16025062 BACKGROUND

• 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.

  PMID: 16496552 BACKGROUND

• 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.

  PMID: 19126986 BACKGROUND

MeSH Terms

Conditions

Benign Paroxysmal Positional Vertigo; Vertigo; Dizziness; Vestibular Diseases

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sensation Disorders

Study Officials

• Murat H Ozkul, M.D.

  StatejikYG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Every enrolled patients records were randomized, and based on the outcome, subjects were either assigned to control or experimental arm groups. A report detailing the outcome, but omitting the method of treatment, was given to patients and their care provider.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Medical Officer (CMO)

Model Details: Patients previously diagnosed with BPPV were referred to vestibular laboratory at the Department of Otolaryngology at Haseki Sultangazi Teaching and Research Hospital. Videonystagmography was performed on all subjects to confirm the BPPV diagnosis. Patients were then randomly divided into two groups; experimental and control. The experimental group was treated with RMS, while control group was treated with traditional manual canalith repositioning maneuvers on an examination table.

Study Record Dates

• First Submitted: April 23, 2022
• First Posted: April 29, 2022
• Study Start: February 15, 2022
• Primary Completion: April 12, 2022
• Study Completion: April 23, 2022
• Last Updated: April 29, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)