Multimodal nocturnal seizure detection in children with epilepsy: A prospective, multicenter, long‐term, in‐home trial

Abstract

ObjectiveThere is a pressing need for reliable automated seizure detection in epilepsy care. Performance evidence on ambulatory non‐electroencephalography‐based seizure detection devices is low, and evidence on their effect on caregiver's stress, sleep, and quality of life (QoL) is still lacking. We aimed to determine the performance of NightWatch, a wearable nocturnal seizure detection device, in children with epilepsy in the family home setting and to assess its impact on caregiver burden.MethodsWe conducted a phase 4, multicenter, prospective, video‐controlled, in‐home NightWatch implementation study (NCT03909984). We included children aged 4–16 years, with ≥1 weekly nocturnal major motor seizure, living at home. We compared a 2‐month baseline period with a 2‐month NightWatch intervention. The primary outcome was the detection performance of NightWatch for major motor seizures (focal to bilateral or generalized tonic–clonic [TC] seizures, focal to bilateral or generalized tonic seizures lasting >30 s, hyperkinetic seizures, and a remainder category of focal to bilateral or generalized clonic seizures and "TC‐like" seizures). Secondary outcomes included caregivers' stress (Caregiver Strain Index [CSI]), sleep (Pittsburgh Quality of Sleep Index), and QoL (EuroQol five‐dimension five‐level scale).ResultsWe included 53 children (55% male, mean age = 9.7 ± 3.6 years, 68% learning disability) and analyzed 2310 nights (28 173 h), including 552 major motor seizures. Nineteen participants did not experience any episode of interest during the trial. The median detection sensitivity per participant was 100% (range = 46%–100%), and the median individual false alarm rate was .04 per hour (range = 0–.53). Caregiver's stress decreased significantly (mean total CSI score = 8.0 vs. 7.1, p = .032), whereas caregiver's sleep and QoL did not change significantly during the trial.SignificanceThe NightWatch system demonstrated high sensitivity for detecting nocturnal major motor seizures in children in a family home setting and reduced caregiver stress.

Detection of seizures with ictal tachycardia, using heart rate variability and patient adaptive logistic regression machine learning methods: A hospital‐based validation study

“…The FAR was very low (.25/24 h) compared with other studies seeking to detect focal seizures using non‐EEG devices 16,22,23 . Support vector machine algorithms using HR data was tested in two different studies in order to increase performance and lower FAR, but both studies reported an unacceptably high FAR of >10/24 h, 23 however, the study did not divide the patients into responder and non‐responders which almost certainly diminishes the performance of the seizure detection algorithms.…”

Wearable detection of tonic seizures in childhood epilepsy: An exploratory cohort study

“…A more recent paper from the same group investigated the effect on caregiver stress of a detection device. They describe a significant decrease in caregiver stress, although no change was seen in caregiver's sleep and quality of life 34 …”

“…They do not mention a separate performance concerning TS, but overall sensitivity for motor seizures was 79.4%, although specificity was lower at 55.5%. In a later study by the same group studying the same device, 53% (16/30) of tonic seizures >30 s were detected 34 . Larsen et al used surface EMG as a sole detection biosignal in six patients, detecting TS with an algorithm 12 .…”

“…In a later study by the same group studying the same device, 53% (16/30) of tonic seizures >30 s were detected. 34 Larsen et al used surface EMG as a sole detection biosignal in six patients, detecting TS with an algorithm. 12 Their maximum sensitivity was 63% with a FAR of 4.03/h.…”

“…They describe a significant decrease in caregiver stress, although no change was seen in caregiver's sleep and quality of life. 34 From a usability perspective, we have information from adult questionnaires using the PnP system. 10 After using the PnP system, they reported a median score of 7 (interquartile range 6-8) for both future daily usability and comfort of use (zero = very unlikely/uncomfortable, 10 = highly likely/comfortable).…”