Smartwatch seizure detection app achieves near-perfect sensitivity in trial

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Parkinson’s Disease May Have Link to Stroke March 2017 

Smartwatches Able to Detect Very Early Signs of Parkinson's July 2023 

The latest here:

Smartwatch seizure detection app achieves near-perfect sensitivity in trial

The EpiWatch seizure detection app identified tonic-clonic seizures with 98% sensitivity and an exceptionally low false alarm rate of just 1 false alert every 12.4 days in a multicentre phase 3 study, published in the journal Neurology.

The findings suggest the wearable technology could improve safety for patients with epilepsy -- particularly those at risk for sudden unexpected death in epilepsy (SUDEP) -- while addressing major barriers to adoption seen with existing seizure detection devices.

“For people who have uncontrolled tonic-clonic seizures, which can include a loss of muscle tone and airway obstruction, the risk of SUDEP is high, particularly for those who sleep alone,” said James W. Wheless, MD, Le Bonheur Children’s Hospital, Memphis, Tennessee. “Wearable seizure detection devices can alert caregivers so they can provide first aid, but some devices have high false alarm rates that can discourage use and timely intervention. Our study found the EpiWatch smartwatch app detected nearly all tonic-clonic seizures in participants and had a lower rate of false alarms.”

The study was conducted across 6 epilepsy monitoring units between September 2021 and October 202, enrolling 242 children and adults aged ≥5 years with a history or risk of tonic-clonic seizures who underwent inpatient video-EEG monitoring. Participants wore the smartwatch on the wrist opposite their seizure focus, and seizure detections generated by EpiWatch were compared against independently verified seizure events reviewed by a blinded panel of epileptologists. 

The study’s co-primary endpoints were seizure detection sensitivity and false alarm rate per 24 hours, with additional analyses assessing detection speed and night-time performance.

EpiWatch detected 46 of 47 verified tonic-clonic seizures, yielding an overall sensitivity of 98%. The single missed seizure occurred when a caregiver physically restrained the participant’s arm during the event. Across more than 16,000 hours of monitoring, only 56 false alarms were recorded, corresponding to a false alarm rate of 0.08 per 24 hours -- approximately 1 false alert every 12.4 days and roughly one-tenth the rate reported for other seizure detection devices. 

Median detection latency was 31.5 seconds, and all tonic-clonic seizures occurring during sleep were successfully identified. 

No adverse events were reported. 

“Wearing some seizure monitoring devices may carry a stigma, but using a common smartwatch with an app does not, which is important for encouraging regular use,” said Dr. Wheless. “Being prescribed an app with fewer false alarms can encourage long-term use and provide reliable caregiver alerts to help reduce sudden unexpected deaths and other risks associated with tonic-clonic seizures.”

A limitation of the study was that all seizures occurred in the controlled environment of an epilepsy monitoring unit and may not represent the variety of conditions in which people experience seizures.

Funding for the study was provided by EpiWatch.

Reference: https://www.neurology.org/doi/10.1212/WN9.0000000000000111

SOURCE: American Academy of Neurology