CClinicalTrials.gg
Not yet recruitingNCT06180538EPIVIEWSUpdated Dec 22, 2023

Exploring Patient Impact & Value in Epilepsy Wearables for Seizure Monitoring

An observational study in Epilepsy, sponsored by Royal College of Surgeons, Ireland. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-22.

Sponsored by Royal College of Surgeons, Ireland · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this research study Is to determine the accuracy and reliability of the wearable device in a controlled environment. This study will inform patients, healthcare professionals, and the wider community of the accuracy of the device in detecting seizures.

Read the detailed description

Epilepsy is a common serious neurological disorder, regularly presenting with seizures that can affect patients without warning. Any seizure has the potential to cause significant injury to patients or sudden unexplained death in epilepsy (SUDEP). As such, many patients with epilepsy and their caregivers live with a fear that a seizure may occur, fundamentally impacting their quality of life.

New technology including the use of wearable devices have the potential to identify a seizure and notify caregivers immediately of a person in danger. These devices use sensors that look out for the types of movements demonstrated during a seizure and are able to send alerts automatically when connected to a smartphone and the internet. One example of this device is the Empatica Embrace2 which is a wrist worn wearable that has been approved for use in epilepsy. This relatively new technology is available to purchase by the public, but it is not yet clear what value this device offers.

Whilst man of these devices may be been cleared for use by regulators and available to buy on the consumer market. It remains unclear on the value that they can offer to patients. The purpose of this research study Is to determine the accuracy and reliability of the wearable device in a controlled environment. This study will inform patients, healthcare professionals, and the wider community of the accuracy of the device in detecting seizures.

02

Conditions studied

  • Epilepsy

Keywords

  • wearable device
03

In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's planned enrollment of 50 is below the median of 102 across 521 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

Royal College of Surgeons, Ireland is the lead sponsor of 93 studies on the registry; 44 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients from the Epilepsy Monitoring Unit in Beaumont Hospital who have a history of tonic-clonic seizures

Inclusion criteria

  1. The participant is over the age of 18
  2. The participant has access to a smartphone
  3. The participant has a history of generalised tonic-clonic seizures in the past year

Exclusion criteria

Exclusion Criteria:

  1. The participant lacks capacity to give informed consent (e.g. has intellectual disability)
  2. The participant is a paediatric patient (aged below 18)
05

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Quality of Life in Epilepsy Inventory (QOLIE-31)

    Time frame: Prior to admission

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06180538
Lead sponsor
Royal College of Surgeons, Ireland
Collaborators
Beaumont Hospital
Responsible party
Sponsor
First posted
Dec 22, 2023
Start date
Jan 2024 (estimated)
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Dec 22, 2023

Study contacts

John David Damalerio
Contact
johndaviddamale22@rcsi.com
+353 83 017 0056

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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