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

Benign Paroxysmal Positional Vertigo Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05352555
• Other study ID #: SYG-RMS-18
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 15, 2022
• Est. completion date: April 23, 2022

Study information

• Verified date: April 2022
• Source: Stratejik Yenilikci Girisimler Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 23, 2022
• Est. primary completion date: April 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Benign Paroxysmal Positional Vertigo
• Dizziness
• Vertigo

Intervention

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:
• 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.

Locations

Country	Name	City	State
Turkey	Haseki Sultangazi Training and Research Hospital	Istanbul	Sultangazi

Sponsors (2)

Lead Sponsor	Collaborator
Stratejik Yenilikci Girisimler Ltd.	Haseki Sultangazi Teaching and Research Hospital, University of Health Sciences

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

West N, Hansen S, Møller 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. — View Citation

Yanik B, Külcü DG, Kurtais Y, Boynukalin S, Kurtarah H, Gökmen 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Treatments	Number of treatment necessary to achieve resolution of vertigo and nystagmus	1 month (30 days)
Primary	Treatment success	Number of subjects achieving resolution of vertigo and nystagmus after one treatment	After treatment: 1 week - 1 month (30 days)
Secondary	Vertigo-Dizziness Imbalance (VDI) questionnaire	Comparison of pre-treatment and post-treatment score based on symptoms and quality of life	1 month (30 days)
Secondary	Adverse events	Registration of adverse events and safety issues related to RMS.	1 month (30 days)