A Phase 1/2 interventional study of Automated vertigo repositioning chair and Canalith Reposition Maneuver in Benign Paroxysmal Positional Vertigo, sponsored by Stratejik Yenilikci Girisimler Ltd.. Completed at 1 site in Turkey. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-04-29.
Sponsored by Stratejik Yenilikci Girisimler Ltd. · Phase 1/2, Interventional, and Treatment
Comparison of treatment efficacy of an automated robotic maneuvering system (RMS) repositioning chair versus manual positioning maneuvers in Benign Paroxysmal Positional Vertigo.
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.
248 studies on the registry are indexed under Vertigo; 39 are open to participants now.
This study's enrollment of 75 is above the median of 57 across 186 interventional studies indexed under Vertigo.
Browse Vertigo studies →Stratejik Yenilikci Girisimler Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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
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 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)
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
Number of Treatments
Number of treatment necessary to achieve resolution of vertigo and nystagmus
Time frame: 1 month (30 days)
Treatment success
Number of subjects achieving resolution of vertigo and nystagmus after one treatment
Time frame: After treatment: 1 week - 1 month (30 days)
Vertigo-Dizziness Imbalance (VDI) questionnaire
Comparison of pre-treatment and post-treatment score based on symptoms and quality of life
Time frame: 1 month (30 days)
Adverse events
Registration of adverse events and safety issues related to RMS.
Time frame: 1 month (30 days)
Plan to share: No
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Stratejik Yenilikci Girisimler Ltd.