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Tongue injury among patients with epilepsy undergoing video-encephalographic monitoring

A prospective, randomised controlled trial: Evaluating the use of mouthguards to reduce tongue injury among epilepsy patients undergoing video electroencephalography (VEEG) monitoring

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620001022954
Enrollment
5
Registered
2020-10-08
Start date
2020-09-14
Completion date
2021-12-17
Last updated
2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

In this study, 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.

Interventions

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 mou

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.

Sponsors

Royal Prince Alfred Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
16 Years to 90 Years
Healthy volunteers
No

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

Exclusion criteria

* psychogenic non-epileptic disorder * atonic seizure disorder * less than 16 or more than 90 years of age.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026