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

Primary Purpose

Benign Paroxysmal Positional Vertigo

Status
Completed
Phase
Phase 1
Locations
Turkey
Study Type
Interventional
Intervention
Automated vertigo repositioning chair
Canalith Reposition Maneuver
Sponsored by
Stratejik Yenilikci Girisimler Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Paroxysmal Positional Vertigo focused on measuring Automated, Robotic, Vertigo, Epley maneuver, RMS chair, Reposition chair, Dizziness, Vestibular diseases, Multi canal BPPV

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Haseki Sultangazi Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Robotic Maneuvering System (RMS)

Canalith Reposition Maneuver

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Treatments
Number of treatment necessary to achieve resolution of vertigo and nystagmus
Treatment success
Number of subjects achieving resolution of vertigo and nystagmus after one treatment

Secondary Outcome Measures

Vertigo-Dizziness Imbalance (VDI) questionnaire
Comparison of pre-treatment and post-treatment score based on symptoms and quality of life
Adverse events
Registration of adverse events and safety issues related to RMS.

Full Information

First Posted
April 23, 2022
Last Updated
April 23, 2022
Sponsor
Stratejik Yenilikci Girisimler Ltd.
Collaborators
Haseki Sultangazi Teaching and Research Hospital, University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05352555
Brief Title
Automated Robotic Maneuvering System (RMS) vs Manual Reposition Maneuver in Treatment of Benign Paroxysmal Positional Vertigo (BPPV)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
April 12, 2022 (Actual)
Study Completion Date
April 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stratejik Yenilikci Girisimler Ltd.
Collaborators
Haseki Sultangazi Teaching and Research Hospital, University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Paroxysmal Positional Vertigo
Keywords
Automated, Robotic, Vertigo, Epley maneuver, RMS chair, Reposition chair, Dizziness, Vestibular diseases, Multi canal BPPV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare Provider
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.
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Robotic Maneuvering System (RMS)
Arm Type
Experimental
Arm Description
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.
Arm Title
Canalith Reposition Maneuver
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Automated vertigo repositioning chair
Other Intervention Name(s)
Robotic Maneuvering System (RMS)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Canalith Reposition Maneuver
Other Intervention Name(s)
Manual Reposition Maneuver
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Treatments
Description
Number of treatment necessary to achieve resolution of vertigo and nystagmus
Time Frame
1 month (30 days)
Title
Treatment success
Description
Number of subjects achieving resolution of vertigo and nystagmus after one treatment
Time Frame
After treatment: 1 week - 1 month (30 days)
Secondary Outcome Measure Information:
Title
Vertigo-Dizziness Imbalance (VDI) questionnaire
Description
Comparison of pre-treatment and post-treatment score based on symptoms and quality of life
Time Frame
1 month (30 days)
Title
Adverse events
Description
Registration of adverse events and safety issues related to RMS.
Time Frame
1 month (30 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Murat H Ozkul, M.D.
Organizational Affiliation
StatejikYG
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haseki Sultangazi Training and Research Hospital
City
Istanbul
State/Province
Sultangazi
ZIP/Postal Code
34265
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24807849
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.
Results Reference
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PubMed Identifier
17003735
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. doi: 10.1097/01.mlg.0000231291.44818.be.
Results Reference
background
PubMed Identifier
25749489
Citation
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.
Results Reference
background
PubMed Identifier
18973840
Citation
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.
Results Reference
background
PubMed Identifier
32784154
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.
Results Reference
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PubMed Identifier
16025062
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. doi: 10.1016/j.otohns.2005.03.027.
Results Reference
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PubMed Identifier
16496552
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.
Results Reference
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PubMed Identifier
19126986
Citation
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.
Results Reference
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Automated Robotic Maneuvering System (RMS) vs Manual Reposition Maneuver in Treatment of Benign Paroxysmal Positional Vertigo (BPPV)

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