Automated Robotic Maneuvering System (RMS) vs Manual Reposition Maneuver in Treatment of Benign Paroxysmal Positional Vertigo (BPPV)
NCT ID: NCT05352555
Last Updated: 2022-04-29
Study Results
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Basic Information
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COMPLETED
PHASE1/PHASE2
75 participants
INTERVENTIONAL
2022-02-15
2022-04-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Robotic Maneuvering System (RMS)
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.
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).
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.
Canalith Reposition Maneuver
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.
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:
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.
Interventions
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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).
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.
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:
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Positive Dix-Hallpike
* Positive supine roll test
* Positive Deep Head Hanging
* Vertigo-Dizziness Imbalance symptom scores compatible with BPPV
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Haseki Sultangazi Teaching and Research Hospital, University of Health Sciences
UNKNOWN
Stratejik Yenilikci Girisimler Ltd.
INDUSTRY
Responsible Party
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Murat Haluk Ozkul
Chief Medical Officer (CMO)
Principal Investigators
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Murat H Ozkul, M.D.
Role: PRINCIPAL_INVESTIGATOR
StatejikYG
Locations
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Haseki Sultangazi Training and Research Hospital
Istanbul, Sultangazi, Turkey (Türkiye)
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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SYG-RMS-18
Identifier Type: -
Identifier Source: org_study_id
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