Benign Paroxysmal Positional Vertigo
Conditions
Keywords
Automated, Robotic, Vertigo, Epley maneuver, RMS chair, Reposition chair, Dizziness, Vestibular diseases, Multi canal BPPV
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.
Interventions
DEVICEAutomated 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). 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.
OTHERCanalith 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: 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.
Sponsors
Haseki Sultangazi Teaching and Research Hospital, University of Health Sciences
Stratejik Yenilikci Girisimler Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatments | 1 month (30 days) | Number of treatment necessary to achieve resolution of vertigo and nystagmus |
| Treatment success | After treatment: 1 week - 1 month (30 days) | Number of subjects achieving resolution of vertigo and nystagmus after one treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed