None listed
Conditions
Brief summary
This study is being conducted to find out if the ROMI device can help patients with dizziness to be sent to the right specialist (e.g. vestibular physiotherapist, neurologist) first time rather than a long wait to be assessed by an ENT. This study employs a randomised, controlled trial design to assess both the predictive value and clinical utility of the ROMI test as a triage of those with episodic dizziness. The ROMI is a portable device that allows patients to capture their eye movements during dizziness attacks. Patients referred with undiagnosed vertigo will be prospectively randomised into either a control group which will undergo standard care or into the interventional group which will use the portable diagnostic device and also the standard care pathways. Participants that undertake the ROMI test will do so while on the ENT waitlist and will see the ENT specialist on the date of their allotted appointment with the results of the ROMI test (assessed by an Audiologist) provided to the ENT specialist .
Interventions
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.
Sponsors
Study design
Eligibility
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
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