Clinical trial NCT05352555: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Benign Paroxysmal Positional Vertigo
Keywords: Automated
Robotic
Vertigo
Epley maneuver
RMS chair
Reposition chair
Dizziness
Vestibular diseases
Multi canal BPPV
Lead sponsor: Stratejik Yenilikci Girisimler Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Haseki Sultangazi Teaching and Research Hospital, University of Health Sciences
First posted: 2022-04-29
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of Treatments
timeFrame: 1 month (30 days)
measure: Treatment success
timeFrame: After treatment: 1 week - 1 month (30 days)
Secondary outcomes:
measure: Vertigo-Dizziness Imbalance (VDI) questionnaire
timeFrame: 1 month (30 days)
measure: Adverse events
timeFrame: 1 month (30 days)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haseki Sultangazi Training and Research Hospital
state: Sultangazi
Study officials:
affiliation: StatejikYG
name: Murat H Ozkul, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.