Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001022954
Ethics application status
Approved
Date submitted
14/08/2020
Date registered
8/10/2020
Date last updated
17/08/2022
Date data sharing statement initially provided
8/10/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Tongue injury among patients with epilepsy undergoing video-encephalographic monitoring
Scientific title
A prospective, randomised controlled trial: Evaluating the use of mouthguards to reduce tongue injury among epilepsy patients undergoing video electroencephalography (VEEG) monitoring
Secondary ID [1] 302001 0
None
Universal Trial Number (UTN)
U1111-1256-6548
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tongue injury 318559 0
Condition category
Condition code
Injuries and Accidents 316573 316573 0 0
Other injuries and accidents
Neurological 316970 316970 0 0
Epilepsy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aim: We plan to investigate the effectiveness of mouthguards to prevent or minimise tongue injury among epilepsy patients who are undergoing VEEG or Stereotactic EEG (SEEG) monitoring.
Study Design and Setting: A prospective, randomised controlled intervention study will be conducted from September 2020 to September 2023 in the EMU Neurology Ward at Royal Prince Alfred Hospital. At admission to the EMU, patients will be randomised into two groups. Group 1:Standard Care Group will not receive mouthguards. Group 2:Active Care Group w will receive a mouthguard for application to lower teeth.
All the nurses who will be involved in performing VEEG monitoring will receive training about the study protocol before commencing the research. A training log for the nurses who will be performing the test will be maintained.
Procedures:
Pre-application assessment: Trained neurophysiology nurses will interview all patients who are eligible for the study and complete a demographic data form during the EMU admission process.
Application of mouthguards: To maintain a standardised mouthguard placement and follow up care process, we will use the following product: 'Commercially available dental guard' mouthguard. The mouthguard works to keep upper and lower teeth apart by placing molar pads on both lower teeth. The pads cover at least half of the last molar and are secured by an adjustable strap over the lower teeth.
Step 1 (Group2):
The nurse will assist the patient in placing the mouthguard by adjusting a strap to fit the patient's teeth.
Step 2:
Group1: No mouthguard
Group 2: After reducing AEDS, the nurse will apply the mouthguard to the patient's upper and lower teeth. The patient must wear a mouthguard during sleep and intermittently during daytime ( e.g. remove eating meals and talking until the cessation of their VEEG monitoring, or they have two generalised seizures.
Day 2- 7 (Post mouthguards application): If the patient has a focal to bilateral tonic-clonic seizure or a generalised seizure, the nurse will assess the patient's tongue and take pictures. A nurse who is not involved in the VEEG monitoring will complete a tongue assessment based on the digital photograph in a blinded fashion. Photos will be un-notated. This blind nurse will not know the intervention allocation schedule, which will be maintained by the study nurses.
Before discharge from the hospital: The nurse will ask the patient in group 2 to complete a self-report questionnaire to evaluate mouthguards' comfort during VEEG or SEEG monitoring.
Intervention code [1] 318286 0
Prevention
Comparator / control treatment
Group 1: Standard Care Group will not receive mouthguards. Group 2: Active Care Group will receive mouthguards. The standard care group is the patients do not wear mouthguards..
Control group
Active

Outcomes
Primary outcome [1] 324706 0
The primary outcome under study is the incidence of tongue injury. Most patients have one or two seizures with tongue biting; therefore, We will be recorded up to two injuries per assessment during VEEG or SEEG monitoring. The outcome will be assessed by the data collection form which includes the incidence of tongue injury and the picture of the patient's tongue injury during the monitoring.
Timepoint [1] 324706 0
The outcome will occur or not occur immediately following an induced seizure daily VEEG or SEEG monitoring.
Secondary outcome [1] 385436 0
The secondary outcome of interest is the severity of tongue injury among those participants who are injured. The outcome will be score-based. The tongue assessment tool is designed specifically for this study and will collect information on the location and severity of tongue injury. Tongue injury will be graded from 1 (erythema) to 3 (laceration). A total tongue injury score will be yielded for each participant by adding all scores for all tongue injuries.
Timepoint [1] 385436 0
The outcome will occur or not occur immediately following an induced seizure. If there is an injury, it will be scored at the time. daily during VEEG or SEEG monitoring
Secondary outcome [2] 386788 0
The third outcome of interest is patient comfort regarding wearing the mouth guard. A survey consisting of seven self-reported questions which seek Likert scale responses will be used to assess these questionnaires (Mouth Guard Comfort Questionnaires ). It was designed specifically for this study.
Timepoint [2] 386788 0
The outcome will be assessed by the survey will be administered on the last day of VEEG or SEEG monitoring.

Eligibility
Key inclusion criteria
All epilepsy patients with a focal to bilateral tonic-clonic generalised seizure or generalised seizures are eligible for this study if they are older than 16 years of age and have valid neurologist referrals for VEEG or SEEG monitoring between 2-7 days
Minimum age
16 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* psychogenic non-epileptic disorder
* atonic seizure disorder
* less than 16 or more than 90 years of age.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed envelopes will be used by a research nurse who will be blind to allocation to group. The randomisation envelope will be opened after the research nurse obtains informed consent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computerised sequence generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Univariate statistical analyses will be employed to assess equivalence between the two groups on the baseline and to compare the groups on primary and secondary outcome. Multivariate statistical analyses will be employed to assess any associations of demographic covariates to the primary and secondary outcomes and accommodate these in the by-group comparison.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
14/09/2020
Date of last participant enrolment
Anticipated
25/09/2024
Actual
17/12/2021
Date of last data collection
Anticipated
29/09/2024
Actual
Sample size
Target
66
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17226 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 30937 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 306421 0
Hospital
Name [1] 306421 0
Royal Prince Alfred Hospital
Country [1] 306421 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
Royal Prince Alfred Hospital
Comprehensive epilepsy service
50 Missenden Road
Camperdown, Sydney
NSW 2050
Country
Australia
Secondary sponsor category [1] 307248 0
None
Name [1] 307248 0
Address [1] 307248 0
Country [1] 307248 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306618 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 306618 0
Ethics committee country [1] 306618 0
Australia
Date submitted for ethics approval [1] 306618 0
11/06/2020
Approval date [1] 306618 0
12/06/2020
Ethics approval number [1] 306618 0
X20-0166

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

Contacts
Principal investigator
Name 104486 0
A/Prof Armin Nikpour
Address 104486 0
Royal Prince Alfred Hospital & The University of Sydney
COMPREHENSIVE EPILEPSY SERVICE
50 Missenden Road, CAMPERDOWN, NSW 2050
AUSTRALIA
Country 104486 0
Australia
Phone 104486 0
+61295157558
Fax 104486 0
+61295157564
Email 104486 0
[email protected]
Contact person for public queries
Name 104487 0
Sumika Ouchida
Address 104487 0
Royal Prince Alfred Hospital & The University of Sydney
COMPREHENSIVE EPILEPSY SERVICE
50 Missenden Road, CAMPERDOWN, NSW 2050
AUSTRALIA
Country 104487 0
Australia
Phone 104487 0
+61295153928
Fax 104487 0
+61295157564
Email 104487 0
[email protected]
Contact person for scientific queries
Name 104488 0
Sumika Ouchida
Address 104488 0
Royal Prince Alfred Hospital & The University of Sydney
COMPREHENSIVE EPILEPSY SERVICE
50 Missenden Road, CAMPERDOWN, NSW 2050
AUSTRALIA
Country 104488 0
Australia
Phone 104488 0
+61295153928
Fax 104488 0
+61295157564
Email 104488 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The entire dataset
When will data be available (start and end dates)?
The data will be available for 5 years after publication.
Available to whom?
Authorised meta-analysts who have sought ethical approval to access the data
Available for what types of analyses?
Meta-analytic
How or where can data be obtained?
From Coordinator ([email protected]. gov.au)


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9117Ethical approval    380357-(Uploaded-09-09-2020-20-47-56)-Study-related document.pdf



Results publications and other study-related documents

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