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Routine cardiorespiratory and sleep monitoring in an epilepsy monitoring unit

Routine cardiorespiratory and sleep monitoring during video-electroencephalogram (EEG) monitoring: A polysomnography study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12621000923864
Acronym
None
Enrollment
1200
Registered
2021-07-15
Start date
2021-07-26
Completion date
2026-07-27
Last updated
2021-07-21

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

Conditions

None listed

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.

Interventions

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 i

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.

Sponsors

Alfred Health
Lead SponsorHospital

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

• Patients who are on CPAP treatment during the monitoring period.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026