Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000341729
Ethics application status
Approved
Date submitted
15/02/2022
Date registered
24/02/2022
Date last updated
20/02/2023
Date data sharing statement initially provided
24/02/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of Outpatient Measurement of Eyelid Movements in Non-epileptic Seizure Patients
Scientific title
Feasibility of Outpatient Measurement of Eyelid Movements using Eagle Wireless Glasses in Non-epileptic Seizure Patients
Secondary ID [1] 306444 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Seizures 325282 0
Condition category
Condition code
Neurological 322683 322683 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single-site, prospective, pilot study using glasses (“Eagle Wireless Glasses”), which measures eyelid movements using infrared reflectance oculography. Adult (18 years or older) participants, pre-diagnosed with Non-Epileptic Seizure (NES) admitted or attending The Alfred Hospital meeting the selection criteria will be invited to participate in the study. Enrolled participants will be fitted and asked to wear the Eagle Wireless Glasses whilst doing a standardized vigilance test during a clinical visit. This is a 15 minute test that requires the participant to respond via button press to a shape changing on a monitor in front of them. They will then wear the glasses at home, during waking hours, for the subsequent week and record any seizures in a seizure diary. Ocular parameters will be recorded during wakefulness. A analysis of the times wearing glasses will be made against a number of parameters including total time worn during the week, wearing prior to a seizure, wearing during a seizure and wearing in the 15 minutes after a seizure.
Intervention code [1] 322875 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330478 0
To assess the level of compliance in wearing glasses for the purpose of measuring eyelid movements with/without relation to seizures in an outpatient setting.
This assessment is done by comparison of the recorded eyelid movement in relation to trial period and also in relation to seizure times as recorded in their seizure diary. Recorded eyelid movements will be assessed at the end of the trial from the downloaded data.
Timepoint [1] 330478 0
The participant wear the glasses during their waking hours when outside of the clinic and record any seizure in their seizure diary for a period of a week.. Data may be assessed during the week to ensure data quality is being maintained. Analysis of compliance shall be done after the participant has completed their part of the study.
Primary outcome [2] 330479 0
To examine the level of acceptance of wearing specialized glasses in an outpatient setting, a questionnaire specific for this study has been developed.
Timepoint [2] 330479 0
Enrolled participants will complete a questionnaire at the end of their week of wearing the glasses. These questionnaires will be compiled and assessed after all participants have completed the study.
Primary outcome [3] 330507 0
To examine any changes in blink characteristics of wearing specialized glasses in an outpatient setting. Characteristics include inter-blink parameters such as blink rate and intra-blink characteristics such as amplitude-velocity ratio, blink total duration and blink eyelid closure duration.
Timepoint [3] 330507 0
The data collected during the measurements in the clinical setting will be compared with the data collected during the week of glasses usage. This analysis shall be done after all study data has been collected.
Secondary outcome [1] 406387 0
To determine whether there are changes to eyelid movements immediately before, during and following non-epileptic seizures, using the non-invasive wearable device (“Eagle Wireless Glasses”), which measures ocular parameters using infrared reflectance oculography.
Timepoint [1] 406387 0
The analysis of ocular parameters shall be done after all study data has been collected.

Eligibility
Key inclusion criteria
Is able to provide personally signed and dated informed consent to participate in the study or will have a legally authorized representative sign the informed consent on his or her behalf before completing any study-related procedures.

Diagnosed with non-epileptic seizure events by seizure capture during video EEG monitoring.

Minimal frequency of 1 seizure per week
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with prescription glasses with a complex lens prescription that cannot be filled by the standard set of lenses provided by Optalert.

Diagnosed with Epilepsy

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Across 30 participants, cohort compliance measures will also be assessed to determine overall level of compliance. These will also be evaluated with and without reference to their respective seizure events.
Close-ended quantitative questions will be analysed using appropriate statistical measures (mode, median for ordinal scaled and ANOVA, t-test, correlations analysis for interval scaled data). Demographics or open-ended qualitative questions will also be used to perform cross-tabulation with Chi-square analysis or studied independently.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/04/2022
Actual
19/10/2022
Date of last participant enrolment
Anticipated
3/03/2023
Actual
Date of last data collection
Anticipated
10/03/2023
Actual
Sample size
Target
30
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21745 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 36799 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 310791 0
Commercial sector/Industry
Name [1] 310791 0
Optalert
Country [1] 310791 0
Australia
Funding source category [2] 310795 0
Hospital
Name [2] 310795 0
The Alfred
Country [2] 310795 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
Department of Neurology Level 4 (Central Block) The Alfred Hospital 55 Commercial
Road Melbourne, 3004, VIC
Country
Australia
Secondary sponsor category [1] 312037 0
None
Name [1] 312037 0
Address [1] 312037 0
Country [1] 312037 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310364 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 310364 0
The Alfred Hospital 55 Commercial
Road Melbourne, 3004, VIC
Ethics committee country [1] 310364 0
Australia
Date submitted for ethics approval [1] 310364 0
03/02/2022
Approval date [1] 310364 0
23/02/2022
Ethics approval number [1] 310364 0

Summary
Brief summary
The purpose of this study is to assess the level of compliance in wearing glasses for the purpose of measuring eyelid movements in relation to seizures in an outpatient setting. This will be achieved by objective measurement of time worn, in relation to temporal proximity of seizure events as well as using a questionnaire to assess the level of acceptance by participants in using the glasses.

In addition it will be asses whether changes in eyelid movements occur immediately before, during and/or following NES, using the glasses and whether eyelid movements in NES patients exhibit different characteristics than in previously collected eyelid movement data from people without NES, including people with epilepsy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117394 0
Dr Tobias Winton-Brown
Address 117394 0
Department of Neurology
The Alfred Hospital
55 Commercial Road
Melbourne, VIC 3004
Country 117394 0
Australia
Phone 117394 0
+61 481262243
Fax 117394 0
Email 117394 0
[email protected]
Contact person for public queries
Name 117395 0
Dr Tobias Winton-Brown
Address 117395 0
Department of Neurology
The Alfred Hospital
55 Commercial Road
Melbourne, VIC 3004
Country 117395 0
Australia
Phone 117395 0
+61 481262243
Fax 117395 0
Email 117395 0
[email protected]
Contact person for scientific queries
Name 117396 0
Dr Tobias Winton-Brown
Address 117396 0
Department of Neurology
The Alfred Hospital
55 Commercial Road
Melbourne, VIC 3004
Country 117396 0
Australia
Phone 117396 0
+61 481262243
Fax 117396 0
Email 117396 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
The results of this study will be kept confidential.
The results of this study may be published.


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.