Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000833864
Ethics application status
Approved
Date submitted
21/01/2015
Date registered
30/06/2021
Date last updated
30/06/2021
Date data sharing statement initially provided
30/06/2021
Date results information initially provided
30/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Monitoring episodic dizziness outside the clinic
Scientific title
Efficacy of Tele-nystagmography: a new method of remotely monitoring eye movements, for the diagnosis of vestibular disorders causing vertigo in patients experiencing episodic vertigo
Secondary ID [1] 285334 0
nil
Universal Trial Number (UTN)
nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Episodic Dizziness 293061 0
Condition category
Condition code
Ear 293332 293332 0 0
Other ear disorders
Neurological 297165 297165 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomized study comparing the use of a portable balance testing device prototype versus the currently available clinic-based devices in the diagnosis of vestibular disorders causing vertigo. The portable balance testing device is a pair of goggles that contain cameras. Participants in the intervention group are required to take the device home and place over their eyes during an episode of dizziness. This technique is called tele-nystagmography. Participants that in the intervention group are asked to place over their eyes for 3 minutes every time they feel dizzy. They are to use the device for every dizzy episode for two weeks or until the memory on the unit is full (up to 30 recordings).. Patients referred with undiagnosed vertigo will be prospectively randomised into either a control group that will undergo standard vestibular workup which requires multiple visits or into the intervention group which will use the portable diagnostic device and just requires one visit. The approximate duration of a visit is one hour. During this visit, the images recorded will be viewed by the specialist. The novel aspect is that the portable device allows capture of eye movements during vertigo attacks. Current investigations only provide limited information and cause side effects through the active stimulation of the vestibular apparatus. If a diagnosis is not made during the follow-up visit in the intervention group, the participant will undergo the standard vestibular workup.
Intervention code [1] 290248 0
Diagnosis / Prognosis
Comparator / control treatment
The control group will undergo the current management pathway which may include several visits with a specialist ENT (or neurologist) and possibly include further testing including hearing tests, video nystagmography, rotation chair testing and/or Vestibular Evoked Myogenic Potential testing.
Control group
Active

Outcomes
Primary outcome [1] 293163 0
Total number of appointments, This is defined as the number of appointments the patient spends with a specialist (ENT or Neurologist) or audiologist regarding their dizziness. Assessed by review of the patient's hospital medical file
Timepoint [1] 293163 0
Total number of appointments over a 12 month period from the patients initial appointment.
Secondary outcome [1] 310474 0
Number of in-clinic vestibular diagnostic testing appointments determined by patient's hospital records. Diagnostic testing includes video nystagmography, oculography, rotation chair testing and/or Vestibular Evoked Myogenic Potential (VEMP) testing.
Timepoint [1] 310474 0
Total number of in-clinic diagnostic tests undertaken in the 12 month period from the patients initial appointment.

Eligibility
Key inclusion criteria
* Patients referred to Fremantle Hospital ENT Outpatients department that have episodic dizziness as a major symptom
* Participants must be able to physically handle a pair of goggles or have someone capable who is nearly always available to help them administer device.
Minimum age
12 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Patients with a known balance disorder

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)
Patients will be randomised using a sealed envelope system. Sealed opaque envelopes will contain information regarding what group the patient will be allocated to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/01/2013
Date of last participant enrolment
Anticipated
Actual
20/01/2017
Date of last data collection
Anticipated
Actual
20/02/2017
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3023 0
Fremantle Hospital and Health Service - Fremantle
Recruitment postcode(s) [1] 8735 0
6160 - Fremantle

Funding & Sponsors
Funding source category [1] 290014 0
Government body
Name [1] 290014 0
Government of Western Australia Department of Health
Country [1] 290014 0
Australia
Primary sponsor type
Hospital
Name
Fremantle Hospital
Address
Alma St,
Fremantle
WA 6160
Country
Australia
Secondary sponsor category [1] 288702 0
None
Name [1] 288702 0
Address [1] 288702 0
Country [1] 288702 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291722 0
The South Metropolitan Health Service (SMHS) Human Research Ethics Committee (HREC)
Ethics committee address [1] 291722 0
Human Research Ethics Office
South Metropolitan Health Service
PO Box 480
FREMANTLE WA 6959
Ethics committee country [1] 291722 0
Australia
Date submitted for ethics approval [1] 291722 0
Approval date [1] 291722 0
22/10/2012
Ethics approval number [1] 291722 0
12/228

Summary
Brief summary
Prospective randomised study comparing the use of a portable balance testing device prototype versus the currently available clinic-based devices in the diagnosis of vestibular disorders causing vertigo. Patients referred with undiagnosed vertigo will be prospectively randomised into either a control group which will undergo standard vestibular workup or into the interventional group which will use the portable diagnostic device. If a diagnosis is not made in the interventional group, the participant will undergo the standard vestibular workup. The portable device allows to capture the eye movements during the vertigo attacks.
Trial website
Trial related presentations / publications
Public notes
Recruitment only through doctor referral to ENT department

Contacts
Principal investigator
Name 51434 0
Prof Gunesh Rajan
Address 51434 0
Otolaryngology,Head & Neck Surgery
LUKS
Spitalstrasse
CH-6000 Luzern
Switzerland
Country 51434 0
Switzerland
Phone 51434 0
+41412054956
Fax 51434 0
Email 51434 0
[email protected]
Contact person for public queries
Name 51435 0
Gunesh Rajan
Address 51435 0
Otolaryngology,Head & Neck Surgery
LUKS
Spitalstrasse
CH-6000 Luzern
Switzerland
Country 51435 0
Switzerland
Phone 51435 0
+41412054956
Fax 51435 0
Email 51435 0
[email protected]
Contact person for scientific queries
Name 51436 0
Gunesh Rajan
Address 51436 0
Otolaryngology,Head & Neck Surgery
LUKS
Spitalstrasse
CH-6000 Luzern
Switzerland
Country 51436 0
Switzerland
Phone 51436 0
+41412054956
Fax 51436 0
Email 51436 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.