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NCT Number: NCT05352555

Automated Robotic Maneuvering System (RMS) vs Manual Reposition Maneuver in Treatment of 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.

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Key information

Conditions

Benign Paroxysmal Positional Vertigo Dizziness Ear Diseases Labyrinth Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vertigo Vestibular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Haseki Sultangazi Training and Research Hospital

Istanbul, Sultangazi, 34265, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

  • 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)

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:

  • 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

Primary outcomes

  1. Number of Treatments

    Time frame: 1 month (30 days)

    Number of treatment necessary to achieve resolution of vertigo and nystagmus

  2. Treatment success

    Time frame: After treatment: 1 week - 1 month (30 days)

    Number of subjects achieving resolution of vertigo and nystagmus after one treatment

Secondary outcomes

  1. Vertigo-Dizziness Imbalance (VDI) questionnaire

    Time frame: 1 month (30 days)

    Comparison of pre-treatment and post-treatment score based on symptoms and quality of life

  2. Adverse events

    Time frame: 1 month (30 days)

    Registration of adverse events and safety issues related to RMS.

Sponsors and collaborators

Lead sponsor

Stratejik Yenilikci Girisimler Ltd.

Industry

Collaborators

  • Haseki Sultangazi Teaching and Research Hospital, University of Health Sciences

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 29, 2022
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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