Benign Paroxysmal Positional VertigoPhase 1/2NCT05352555

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

A Phase 1/2 study testing Automated vertigo repositioning chair and Canalith Reposition Maneuver in people with Benign Paroxysmal Positional Vertigo, run by Stratejik Yenilikci Girisimler Ltd. at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Comparison of treatment efficacy of an automated robotic maneuvering system (RMS) repositioning chair versus manual positioning maneuvers in Benign Paroxysmal Positional Vertigo. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Benign Paroxysmal Positional Vertigo
What is being tested?: Automated vertigo repositioning chair and Canalith Reposition Maneuver
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 75 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Feb 2022to 23 Apr 2022
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Characteristic positional nystagmus (for BPPV)
Positive Dix-Hallpike
Positive supine roll test
Positive Deep Head Hanging
Vertigo-Dizziness Imbalance symptom scores compatible with BPPV

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Haseki Sultangazi Training and Research Hospital
Istanbul, Sultangazi, 34265

Other trials in Turkey (Türkiye)

About this study

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)

Comparison of treatment efficacy of an automated robotic maneuvering system (RMS) repositioning chair versus manual positioning maneuvers in Benign Paroxysmal Positional Vertigo.

Read the 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.

Conditions: Benign Paroxysmal Positional Vertigo
Being tested: Automated vertigo repositioning chair, Canalith Reposition Maneuver
Keywords: Automated, Robotic, Vertigo, Epley maneuver, RMS chair, Reposition chair, Dizziness, Vestibular diseases, Multi canal BPPV
Medical subject headings: Benign Paroxysmal Positional Vertigo, Vertigo, Dizziness, Vestibular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Automated vertigo repositioning chairDevice
Also called Robotic Maneuvering System (RMS)
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 ManeuverOther
Also called Manual 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.

Study groups in NCT05352555
Study group	Role	What they receive
Robotic Maneuvering System (RMS)	Experimental	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. Receives: Device: Automated vertigo repositioning chair
Canalith Reposition Maneuver	Active comparator	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. Receives: Other: Canalith Reposition Maneuver

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Treatments
Number of treatment necessary to achieve resolution of vertigo and nystagmus
Measured: 1 month (30 days)
Treatment success
Number of subjects achieving resolution of vertigo and nystagmus after one treatment
Measured: After treatment: 1 week - 1 month (30 days)

Secondary outcomes (2)

Vertigo-Dizziness Imbalance (VDI) questionnaire
Comparison of pre-treatment and post-treatment score based on symptoms and quality of life
Measured: 1 month (30 days)
Adverse events
Registration of adverse events and safety issues related to RMS.
Measured: 1 month (30 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 202223 Apr 2022

First posted29 Apr 2022
Study start15 Feb 2022
Primary completion12 Apr 2022
Study completion23 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Benign Paroxysmal Positional VertigoStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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: Double blind
Who is masked: Participant, Care provider
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05352555
Sponsor's protocol ID: SYG-RMS-18
Status last verified: Apr 2022
First submitted: 23 Apr 2022
Last updated: 29 Apr 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 24807849
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.
PubMed 17003735
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.
PubMed 25749489
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.
PubMed 18973840
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.
PubMed 32784154
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.
PubMed 16025062
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.
PubMed 16496552
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.
PubMed 19126986

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effectiveness of Epley Maneuver Versus Semont Maneuver on Dizziness and Balance in Stroke Survivors With Posterior Canal BPPV
Stroke
Not yet recruiting
Epley Versus Semont-plus Maneuver for Benign Paroxysmal Positional Vertigo
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Enrolling by invitationObservational study
Comparison of Two Mechanical Rotation Chairs With Diagnostics of Benign Paroxysmal Positional Vertigo.
Benign Paroxysmal Positional Vertigo (BPPV)
Not yet recruiting
The Effect of Chewing Gum on Dizziness in Patients Diagnosed With Posterior Canal Benign Paroxysmal Positional Vertigo in the Emergency Department
Vertigo Benign Positional, Dizziness
Active, not recruiting
Benign Paroxysmal Positional Vertigo With and Without Vestibular Hypofunction: Protocol for an Integrated Home-Based Exercise With Self-Managed Education Programme
Benign Paroxysmal Positional Vertigo (BPPV), Vestibular Hypofunction

All Benign Paroxysmal Positional Vertigo trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT05352555
Acronym / sponsor ID: SYG-RMS-18
Conditions: Benign Paroxysmal Positional Vertigo
Keywords: Automated, Robotic, Vertigo, Epley maneuver, RMS chair, Reposition chair, Dizziness, Vestibular diseases
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: Stratejik Yenilikci Girisimler Ltd.Industry (pharma, biotech, devices)
Collaborators: Haseki Sultangazi Teaching and Research Hospital, University of Health Sciences
Study start: 15 Feb 2022 (actual)
Primary completion: 12 Apr 2022 (actual)
Study completion: 23 Apr 2022 (actual)
First posted: 29 Apr 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Comparison of treatment efficacy of an automated robotic maneuvering system (RMS) repositioning chair versus manual positioning maneuvers in Benign Paroxysmal Positional Vertigo.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2
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.

Arm	Type	Receives
Robotic Maneuvering System (RMS)	Experimental	Device: Automated vertigo repositioning chairBPPV 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.
Canalith Reposition Maneuver	Active comparator	Other: Canalith Reposition ManeuverBPPV 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Characteristic positional nystagmus (for BPPV)
Positive Dix-Hallpike
Positive supine roll test
Positive Deep Head Hanging
Vertigo-Dizziness Imbalance symptom scores compatible with BPPV

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Automated vertigo repositioning chairAlso: Robotic Maneuvering System (RMS)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.	Device	Robotic Maneuvering System (RMS)
Canalith Reposition ManeuverAlso: Manual Reposition ManeuverPatients 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	Canalith Reposition Maneuver

Primary outcome

Number of Treatments
Time frame: 1 month (30 days)
Number of treatment necessary to achieve resolution of vertigo and nystagmus
Treatment success
Time frame: After treatment: 1 week - 1 month (30 days)
Number of subjects achieving resolution of vertigo and nystagmus after one treatment

2 secondary outcomes

Vertigo-Dizziness Imbalance (VDI) questionnaire
Time frame: 1 month (30 days)
Adverse events
Time frame: 1 month (30 days)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
Background: PubMed 24807849Tan 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.
Background: PubMed 17003735Choung 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.
Background: PubMed 25749489West 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.
Background: PubMed 18973840Bhattacharyya 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.
Background: PubMed 32784154Pedersen 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.
Background: PubMed 16025062Nakayama 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.
Background: PubMed 16496552Richard-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.
Background: PubMed 19126986Yanik 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.
Individual participant dataSharing planned: No

Related trials for Benign Paroxysmal Positional Vertigo

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Effectiveness of Epley Maneuver Versus Semont Maneuver on Dizziness and Balance in Stroke Survivors With Posterior Canal BPPV
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Murat H Ozkul, M.D. principal investigator

StatejikYG

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Treatments (time frame: 1 month (30 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05352555, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.