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Trial registered on ANZCTR


Registration number
ACTRN12619001039178
Ethics application status
Approved
Date submitted
4/07/2019
Date registered
22/07/2019
Date last updated
24/11/2020
Date data sharing statement initially provided
22/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of the Epley Omniax device in the treatment of Benign Paroxysmal Positional Vertigo (BPPV)
Scientific title
Comparing clinical effectiveness of the Epley manoeuvre versus the Somersault manoeuvre using a multi-axial repositioning device for Benign Paroxysmal Positional Vertigo (BPPV)
Secondary ID [1] 297225 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Paroxysmal Positional Vertigo 311287 0
Condition category
Condition code
Ear 309901 309901 0 0
Other ear disorders
Neurological 312021 312021 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be a randomised controlled trial (RCT) comparing two treatment conditions on the Epley Omniax System (EOS) a mechanical treatment system by Vesticon for the treatment of Benign Paroxysmal Positional Vertigo (BPPV). The EOS is a combined
motorized positioning and real time infra-red videooculography system. It consists of a chair with a five-point harness incorporated into a two-axis rotator that allows 360-degree movement
of the whole patient in any direction. Oculomotor characteristics are recorded using the systems infrared video oculography goggles, which have the capture rate of 30 Hz and allow the
removal of visual fixation.This treatment trial will be for the treatment of posterior canal (PC) BPPV using either the mechanical Epley, or Somersault manoeuvres on the EOS as described below. Any nystagmus elicited will be recorded using infra-red video-nystagmography (VNG)
(1) Epley manoeuvre:
* with patients in the seated position, they are rotated to 45 degrees to the affected side, before being tilted to 120 degrees down, awaiting the elicitation of nystagmus and vertigo as per the usual dix-hallpike position. They are then rotated to 90 degrees to opposite side, rolled over and sat up, similar to the bedside Epley manoeuvre.
(2) Somersault manoeuvre:
* With patients in the seated position, they will undergo a 360 degree reverse somersault.

Patients will be randomised into one of two treatment groups. There will be no control group in this study, as current clinical guidelines recommend the treatment of BPPV and therefore withholding treatment would be a breach of ethical guidelines regarding ‘best practice’. Patients will undergo a maximum of 4 clinical treatments in their specified treatment group (i.e. until they display a negative Dix-Hallpike (DHP) test (defined as an absence of PC BPPV nystagmus on repeat DHP testing). The number of treatments per clinical session will be determined by patient tolerance i.e. the presence of nausea or severity of symptoms, and response to treatment, i.e. the presence or absence of nystagmus. This will be used to monitor fidelity of intervention and will be documented in the clinicians notes by either a Physiotherapist or Audiologist administering the intervention.

Initial consultations are 45 minutes and follow up consultations are 30 minutes. The number of clinical sessions depends on whether the BPPV resolves, based on previous studies, this is typically within 4 or less treatment manoeuvres or 2 or less sessions. Alternate treatment manoeuvres will be completed either within the same session or the following session depending on patient tolerance. Treatment sessions will be once per week until the BPPV resolves.

Should patients experience nausea, they will be appropriately managed with antiemetic medications such as stemetil or ondansetron as required, as prescribed by an accompanying Oto-neurologist. Should patients continue to display nystagmus consistent with BPPV after 4 clinical treatments in their selected treatment group, the treatment will be deemed unsuccessful and the patient with be offered the alternate manoeuvre to ensure effective and appropriate clinical care. Should patients experience canal conversion i.e. to horizontal canal BPPV, results will be documented and recorded, and patients will be treated with the alternate treatment manoeuvre as appropriate i.e. Barbeque roll for horizontal canal BPPV. In our earlier study (Power, 2018) patients with PC BPPV, 94% (n = 74/79) experienced relief after three manoeuvres, hence it is anticipated the majority of patients will be effectively treated in 4 or less manoeuvres. These patient treatment procedures do not vary from standard clinic procedures, except for the random allocation to one of two treatment groups.

Power, L., Murray, K., Szmulewicz, D. (2018) Early Experience with a multi-axial, whole body positioning system in the treatment of Benign Paroxysmal Positional Vertigo (BPPV). Journal of Clinical Neuroscience. 61; 186 - 188
Intervention code [1] 313479 0
Treatment: Devices
Comparator / control treatment
Epley manoeuvre will be compared to the somersault manoeuvre
Control group
Active

Outcomes
Primary outcome [1] 318846 0
Dix-Hallpike Manoeuvre (presence or absence of nystagmus on Dix-hallpike manoeuvre)
Timepoint [1] 318846 0
4 or less treatments (assessed immediately after intervention)
Secondary outcome [1] 366226 0
Nausea &/or Vomiting (self-reported)
Timepoint [1] 366226 0
4 or less treatments (assessed immediately after intervention)

Eligibility
Key inclusion criteria
• Aged 18 years and above
• Diagnosed with unilateral Posterior canal BPPV. Diagnosis of PC BPPV is based upon the presence of characteristic nystagmus on Dix Hallpike testing, that is, (1) a period of latency (2) followed by counter clockwise torsional nystagmus, which may have a component of upbeat nystagmus, (3) which then fatigues following a duration of typically less than 30 seconds in the canalithasis variant.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to give informed consent
• Patients with BPPV of bilateral posterior canals, or the horizontal or anterior canals.
• Patients with nystagmus not attributable to BPPV – i.e. central positioning nystagmus (CPN). Note: Patients with concomitant vestibular conditions in conjunction WITH posterior canal BPPV i.e. vestibular migraine or vestibular neuritis will be included in this study as it is not uncommon for these conditions to be co-morbid with BPPV.. The presence of a secondary vestibular disorder can be effectively distinguished by clinical audiologists and physiotherapists trained in the analysis of nystagmus, and the presence of these conditions does not influence with or effect the clinical outcome of the PRMs.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All data collected from the trial will be analyzed using descriptive statistics. Information regarding demographic data or treatment outcomes will be presented graphically using appropriate representations such as bar charts or histograms.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2019
Actual
9/09/2019
Date of last participant enrolment
Anticipated
1/09/2023
Actual
Date of last data collection
Anticipated
1/09/2023
Actual
Sample size
Target
100
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12995 0
The Royal Victorian Eye and Ear Hospital - East Melbourne
Recruitment postcode(s) [1] 25480 0
3002 - East Melbourne

Funding & Sponsors
Funding source category [1] 301772 0
Charities/Societies/Foundations
Name [1] 301772 0
Gandel Philanthropy community assist grant
Country [1] 301772 0
Australia
Primary sponsor type
Hospital
Name
Royal Victorian Eye and Ear Hospital
Address
2 St Andrews Place, East Melbourne, VIC. 3002
Country
Australia
Secondary sponsor category [1] 301517 0
Individual
Name [1] 301517 0
Dr. David Szmulewicz
Address [1] 301517 0
Royal Victorian Eye and Ear Hospital
2 St Andrews Place, East Melbourne, VIC, 3002
Country [1] 301517 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302490 0
Royal Victorian Eye and Ear Hospital
Ethics committee address [1] 302490 0
Ethics committee country [1] 302490 0
Australia
Date submitted for ethics approval [1] 302490 0
29/01/2019
Approval date [1] 302490 0
19/02/2019
Ethics approval number [1] 302490 0
18/1403H

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90402 0
Miss Laura Power
Address 90402 0
Royal Victorian Eye and Ear Hospital
2 St Andrews Place, East Melbourne, VIC, 3002
Country 90402 0
Australia
Phone 90402 0
+61 0490106548
Fax 90402 0
Email 90402 0
[email protected]
Contact person for public queries
Name 90403 0
Laura Power
Address 90403 0
Royal Victorian Eye and Ear Hospital
2 St Andrews Place, East Melbourne, VIC, 3002
Country 90403 0
Australia
Phone 90403 0
+61 0490106548
Fax 90403 0
Email 90403 0
[email protected]
Contact person for scientific queries
Name 90404 0
Laura Power
Address 90404 0
Royal Victorian Eye and Ear Hospital
2 St Andrews Place, East Melbourne, VIC, 3002
Country 90404 0
Australia
Phone 90404 0
+61 0490106548
Fax 90404 0
Email 90404 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.