Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000923864p
Ethics application status
Submitted, not yet approved
Date submitted
17/05/2021
Date registered
15/07/2021
Date last updated
15/07/2021
Date data sharing statement initially provided
15/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Routine cardiorespiratory and sleep monitoring in an epilepsy monitoring unit
Scientific title
Routine cardiorespiratory and sleep monitoring during video-electroencephalogram (EEG) monitoring: A polysomnography study
Secondary ID [1] 304240 0
None
Universal Trial Number (UTN)
None
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
epilepsy 321941 0
non-epileptic seizures 322288 0
psychogenic non-epileptic seizures (PNES) 322289 0
Condition category
Condition code
Neurological 319672 319672 0 0
Epilepsy

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a single-center, prospective, observational post-market study using a Class IIa medical device (“GraelPSG”), developed by Compumedics Limited, which non-invasively measures multiple physiological parameters including heart, muscle, eye movements, breathing and body movements. Adult participants (aged 18 years old or older) admitted for inpatient video-EEG monitoring to the Comprehensive Epilepsy Program at The Alfred Hospital, meeting eligibility criteria will be invited to participate in the study.

Enrolled participants will undergo polysomnography on the final day of their video-EEG monitoring admission. This involves application of the following additional sensors: respiratory inductance plethysmography thoracic and abdominal bands, pulse oximetry to assess peripheral capillary oxygen saturation levels, nasal pressure, electrooculography, electromyography electrodes to the mentalis and sub-mentalis, and dual electromyography electrodes to each anterior tibialis. Equipment will be worn for a maximum of 24 hours in duration. Autonomic, cardiorespiratory, brain and sleep function will be analysed.
Intervention code [1] 320571 0
Early Detection / Screening
Comparator / control treatment
None
Control group
Uncontrolled

Outcomes
Primary outcome [1] 327548 0
T0 analyse cardiac, respiratory, sleep polysomnography physiological data during (ictal) and around (interictal) seizures for seizure detection, using machine learning models. Various features including unprocessed data (e.g., raw electrocardiogram signals) and descriptive data (e.g., median heart rate) data be explored; all physiological variables will be assessed as a composite outcome.
Timepoint [1] 327548 0
This is a cross-sectional study. Data collected during the final day of admission of video-EEG monitoring where polysomnography has been applied, will be analysed.
Secondary outcome [1] 395621 0
T0 analyse cardiac, respiratory, sleep polysomnography physiological data during (ictal) and around (interictal) seizures for seizure prediction, using machine learning models to understand temporal and spatial changes to predict seizures. Various features including unprocessed data (e.g., raw electrocardiogram signals) and descriptive data (e.g., median heart rate) data be explored; all physiological variables will be assessed as a composite outcome.
Timepoint [1] 395621 0
This is a cross-sectional study. Data collected during the final day of admission of video-EEG monitoring where polysomnography has been applied, will be analysed.
Secondary outcome [2] 395622 0
To determine the prevalence of moderate-to-severe sleep-disordered breathing (as defined as an apnea-hypopnea (AHI) index of 15 or more) in patients admitted for video-EEG monitoring using polysomnography.
Timepoint [2] 395622 0
This is a cross-sectional study. Data collected during the final day of admission of video-EEG monitoring where polysomnography has been applied, will be analysed.
Secondary outcome [3] 395623 0
To examine sleep efficacy measurements (e.g., % non-REM sleep) in patients admitted for video-EEG monitoring using polysomnography.
Timepoint [3] 395623 0
This is a cross-sectional study. Data collected during the final day of admission of video-EEG monitoring where polysomnography has been applied, will be analysed.

Eligibility
Key inclusion criteria
• Can provide personally signed and dated informed consent to participate in the study before completing any study related procedures.
• Male or female (aged 18 years or older).
• Possible diagnosis of epilepsy or non-epileptic events and admitted for inpatient video-EEG monitoring.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients who are on CPAP treatment during the monitoring period.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Classification models will be used to predict epochs that contain seizures, are precursors to seizure onset and distinguishing epileptic seizures from non-epileptic seizures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/07/2021
Actual
Date of last participant enrolment
Anticipated
27/07/2026
Actual
Date of last data collection
Anticipated
4/01/2027
Actual
Sample size
Target
1200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19467 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 34059 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 308617 0
Government body
Name [1] 308617 0
Victorian Medical Research Acceleration Fund
Country [1] 308617 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Department of Neurology
Level 4 (Central Block)
The Alfred Hospital
55 Commercial Road
Melbourne, VIC 3004
Country
Australia
Secondary sponsor category [1] 309486 0
None
Name [1] 309486 0
Address [1] 309486 0
Country [1] 309486 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 308549 0
Alfred Hospital Ethics Committee (NHMRC Code EC00315)
Ethics committee address [1] 308549 0
Professor John McNeil
Chair of Ethics Committee
Alfred Hospital Ethics Committee
The Alfred Hospital
55 Commercial Road
Melbourne 3004
Victoria, Australia
Ethics committee country [1] 308549 0
Australia
Date submitted for ethics approval [1] 308549 0
05/03/2021
Approval date [1] 308549 0
Ethics approval number [1] 308549 0

Summary
Brief summary
The primary objective of this study is to use machine learning methods to examine autonomic, cardiorespiratory and sleep function in patients with epilepsy to determine whether this data can be used to detect seizures. We will also examine seizure classification and prediction as secondary objectives using the same approach. We will examine whether autonomic, cardiorespiratory and sleep function can be used to differentiate between epileptic seizures and non-epileptic events. Further, we will also examine the prevalence and risk-factors for sleep-disordered breathing in patients who undergo video-EEG monitoring.
Trial website
None
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 111098 0
Dr Shobi Sivathamboo
Address 111098 0
Level 4 (Centre Block)
Department of Neurology
The Alfred Hospital
55 Commercial Road
Melbourne 3004
Victoria, Australia
Country 111098 0
Australia
Phone 111098 0
+61 3 9903 0924
Fax 111098 0
Email 111098 0
[email protected]
Contact person for public queries
Name 111099 0
Dr Shobi Sivathamboo
Address 111099 0
Level 4 (Centre Block)
Department of Neurology
The Alfred Hospital
55 Commercial Road
Melbourne 3004
Victoria, Australia
Country 111099 0
Australia
Phone 111099 0
+61 3 9903 0924
Fax 111099 0
Email 111099 0
[email protected]
Contact person for scientific queries
Name 111100 0
Dr Shobi Sivathamboo
Address 111100 0
Level 4 (Centre Block)
Department of Neurology
The Alfred Hospital
55 Commercial Road
Melbourne 3004
Victoria, Australia
Country 111100 0
Australia
Phone 111100 0
+61 3 9903 0924
Fax 111100 0
Email 111100 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.