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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001270404
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
11/11/2024
Date registered
Help: Date registered
14/11/2025
Date last updated
Help: Date last updated
14/11/2025
Date data sharing statement initially provided
Help: Data sharing statement date
14/11/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Home use device to triage patients with episodic dizziness
Scientific title
A randomised, controlled trial to determine the feasibility and effectiveness of the use of the ROMI device (a home-use nystagmography tool) to triage patients presenting with vertigo and dizziness symptoms to the appropriate clinical pathway.
Additional trial identifiers [1] 313331 0
NIl
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Episodic dizziness 335689 0
Condition category
Condition code
Ear 332250 332250 0 0
Other ear disorders
Neurological 332251 332251 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This study employs a randomised controlled trial design to assess both the predictive value and clinical utility of the home use ROMI device as a triage of those with episodic dizziness to the appropriate clinical pathway (e.g. Ear Nose and Throat (ENT); Neurology; Physiotherapy) .

The ROMI device is a home-use video nystagmography (VNG) device designed to be used unassisted by the patient to capture eye movements (nystagmus) when they are experiencing dizziness symptoms.

Patients referred to an ENT specialist with unexplained vertigo or dizziness and placed on the ENT Clinic Outpatient waiting list will be prospectively randomised into either a control group or into the intervention group which will use the ROMI device to measure their own eye movements during a dizziness episode.

Participants in the intervention group will attend an one hour appointment with the trial audiologist to be allocated the ROMI device to take home. They will be instructed on how to use the ROMI to capture their eye movements (nystagmus) during their episodes of vertigo or dizziness. To use, the patient starts the device and holds to their face for up to 2 minutes during episodes of dizziness. Multiple recordings can be taken during episodes. The audiologist monitors recordings taken by the patient and contacts the patient if no recordings are taken after 2 weeks to discuss any use issues. If at the 2 week point, enough data has been collected, the trial administrator will organise an appointment to return the device. The participant may keep the device up to a total of 6 weeks. The captured data will be assessed and reviewed by the trial audiologist who will then write a report. The report and results will be made available to the treating ENT at their scheduled ENT appointment.

The participants will be assessed by the ENT according to the current standard of care which may include several visits with a specialist ENT and possibly include further testing that may include hearing tests, in-clinic video nystagmography, rotation chair testing and/or Vestibular Evoked Myogenic Potential testing. Some participants may be referred to another specialist (e.g. Neurologist). The ENT will have the ROMI testing results to use as part of their assessment.

Intervention code [1] 329913 0
Diagnosis / Prognosis
Description of the comparator or control
The controls will be assessed by the ENT according to the current standard of care which may include several visits with a specialist ENT and possibly include further testing including hearing tests, in-clinic video nystagmography, rotation chair testing and/or Vestibular Evoked Myogenic Potential testing. Some participants may be referred to another specialist (e.g. Neurologist).
Control group
Active

Outcomes
Primary outcome [1] 339824 0
Accuracy of the triage in predicting the appropriate clinical pathway based on ROMI data (Ear, Nose and Throat Specialist; Neurologist; Vestibular Physiotherapist; General Practitioner; Other specialist consultation; Undecided /not assigned).
Timepoint [1] 339824 0
1> After ROMI test intervention (by the trial audiologist) within 1 to 2 weeks post intervention 2> After their ENT clinical evaluation (by the ENT) within 1 to 2 weeks of their ENT appointment
Secondary outcome [1] 441527 0
Healthcare costs associated with the patient's dizziness symptoms within a 12 month period of initial ENT appointment
Timepoint [1] 441527 0
12 months after the initial ENT appointment.
Secondary outcome [2] 441528 0
Contribution of the ROMI test to the diagnostic process
Timepoint [2] 441528 0
After their ENT clinical evaluation (by the ENT) within 1 to 2 weeks of their ENT appointment

Eligibility
Key inclusion criteria
1. Referral to the ENT department for vertigo and/or dizziness
2. Appointment with ENT scheduled within the next 6 months
3. Reported symptoms of episodic dizziness or vertigo during intake interview
4. Aged >=18
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
1. Not suitable to operate the ROMI home-use device (determined by Principal Investigator)
2. Currently participating in another clinical study
3. Is an employee or affiliated with the study sponsor

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



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/01/2026
Actual
Date of last participant enrolment
Anticipated
31/08/2027
Actual
Date of last data collection
Anticipated
14/10/2027
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 27301 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [2] 27302 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 43391 0
6150 - Murdoch
Recruitment postcode(s) [2] 43392 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 317783 0
Government body
Name [1] 317783 0
Western Australia Future Health Research & Innovation Fund, Innovation Seed Fund
Country [1] 317783 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Neurotologix Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 320102 0
None
Name [1] 320102 0
Address [1] 320102 0
Country [1] 320102 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316467 0
WA Health Central HREC
Ethics committee address [1] 316467 0
Ethics committee country [1] 316467 0
Australia
Date submitted for ethics approval [1] 316467 0
18/11/2024
Approval date [1] 316467 0
22/10/2025
Ethics approval number [1] 316467 0
PRN: RGS0000007252

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

Contacts
Principal investigator
Name 137982 0
Dr Dayse Tavora-Vieira
Address 137982 0
Audiology Department, Oupatient Clinic 5, Fiona Stanley Hospital, Locked Bag 100, Palmyra DC WA 6961
Country 137982 0
Australia
Phone 137982 0
+61 8 61525668
Fax 137982 0
Email 137982 0
[email protected]
Contact person for public queries
Name 137983 0
Dayse Tavora-Vieira
Address 137983 0
Audiology Department, Oupatient Clinic 5, Fiona Stanley Hospital, Locked Bag 100, Palmyra DC WA 6961
Country 137983 0
Australia
Phone 137983 0
+61 8 61525668
Fax 137983 0
Email 137983 0
[email protected]
Contact person for scientific queries
Name 137984 0
Dayse Tavora-Vieira
Address 137984 0
Audiology Department, Outpatient Clinic 5, Fiona Stanley Hospital, Locked Bag 100, Palmyra DC WA 6961
Country 137984 0
Australia
Phone 137984 0
+61 8 61525668
Fax 137984 0
Email 137984 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.