A Phase III clinical trial has evaluated the EpiWatch app on the Apple Watch for detecting tonic-clonic seizures (TCS) in both children and adults, with findings published in Neurology Open Access.
Key Findings
- The app detected 46 of 47 TCS events, achieving 98% sensitivity. The single missed seizure occurred when the participant's arm was restrained.
- Over 16,189 hours of monitoring, 56 false alarms were recorded—equivalent to one every 12 days. Excluding non-TCS motor seizures, the rate dropped to one false alarm every 18.7 days.
- Median detection latency was 31.5 seconds after clinical onset.
- All 19 TCS during sleep were detected, with no false alarms from normal sleep.
Background
- TCS are associated with sudden unexpected death in epilepsy (SUDEP). Early detection may reduce this risk.
- EpiWatch is an FDA-cleared prescription app that uses movement and physiological signals.
- The trial involved 242 participants in epilepsy monitoring units over two years.
Limitations
- The study was conducted in a controlled hospital setting; real-world performance requires further validation.
- Only TCS in individuals aged 5 and older were evaluated.
Statements
"Wearables are adjuncts to clinical care, not replacements," researchers caution.
- The study was funded by EpiWatch, Inc., with Johns Hopkins researchers involved under conflict-of-interest mitigation procedures.