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

Dutch TeleEpilepsy Consortium; Richard H.C. Lazeron; Johannes P. van Dijk; Roland D. Thijs

doi:10.1111/epi.17654

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

Dutch TeleEpilepsy Consortium, Richard H.C. Lazeron, Johannes P. van Dijk, Roland D. Thijs (Corresponding author)

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

Objective: There 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. Methods: We 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). Results: We 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. Significance: The NightWatch system demonstrated high sensitivity for detecting nocturnal major motor seizures in children in a family home setting and reduced caregiver stress.

Original language	English
Pages (from-to)	2137-2152
Number of pages	16
Journal	Epilepsia
Volume	64
Issue number	8
DOIs	https://doi.org/10.1111/epi.17654
Publication status	Published - Aug 2023

Bibliographical note

Funding Information:
This work was supported by the Netherlands Organization for Health Research and Development (ZonMW; project number 446001009); the Dutch National Epilepsy Fund (EpilepsieNL) and Health Holland (project number 40‐41200‐98‐9335); and the Christelijke Vereniging voor de Verpleging van Lijders aan Epilepsie. LivAssured, the company developing the NightWatch device, has an exclusive license to use the data for commercial purposes in exchange for a percentage of the revenue directed to the University Medical Center Utrecht and Kempenhaeghe. The Dutch Tele‐Epilepsy Consortium will receive research funds if this generates profits. None of the authors has financial interests in LivAssured nor has received or will receive income from future sales of NightWatch. LivAssured and the funding sources had no role in the study design, analysis, or decision to submit for publication.

Funding

This work was supported by the Netherlands Organization for Health Research and Development (ZonMW; project number 446001009); the Dutch National Epilepsy Fund (EpilepsieNL) and Health Holland (project number 40‐41200‐98‐9335); and the Christelijke Vereniging voor de Verpleging van Lijders aan Epilepsie. LivAssured, the company developing the NightWatch device, has an exclusive license to use the data for commercial purposes in exchange for a percentage of the revenue directed to the University Medical Center Utrecht and Kempenhaeghe. The Dutch Tele‐Epilepsy Consortium will receive research funds if this generates profits. None of the authors has financial interests in LivAssured nor has received or will receive income from future sales of NightWatch. LivAssured and the funding sources had no role in the study design, analysis, or decision to submit for publication. This work was supported by the Netherlands Organization for Health Research and Development (ZonMW; project number 446001009); the Dutch National Epilepsy Fund (EpilepsieNL) and Health Holland (project number 40‐41200‐98‐9335); and the Christelijke Vereniging voor de Verpleging van Lijders aan Epilepsie. We would like to thank all children and their caregivers for participating in the PROMISE study. We are especially grateful to Prof. Dr. J. W. Sander for critically reviewing the manuscript, and to Patrick Agterberg, Paula Jansen, Marlies Bakermans, and Ineke Diderich for their contribution to this study.

Funders	Funder number
Christelijke Vereniging voor de Verpleging van Lijders aan Epilepsie
EpilepsieNL
Health~Holland	40‐41200‐98‐9335
ZonMw : Dutch Organisation for Health Research and Development	446001009
Epilepsiefonds

Keywords

caregiver
NightWatch
seizure detection device
SUDEP
wearable

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Cite this

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title = "Multimodal nocturnal seizure detection in children with epilepsy: A prospective, multicenter, long-term, in-home trial",

abstract = "Objective: There 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. Methods: We 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). Results: We 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. Significance: The NightWatch system demonstrated high sensitivity for detecting nocturnal major motor seizures in children in a family home setting and reduced caregiver stress.",

keywords = "caregiver, NightWatch, seizure detection device, SUDEP, wearable",

author = "{Dutch TeleEpilepsy Consortium} and {van Westrhenen}, Anouk and Lazeron, {Richard H.C.} and {van Dijk}, {Johannes P.} and Leijten, {Frans S.S.} and Thijs, {Roland D.}",

note = "Funding Information: This work was supported by the Netherlands Organization for Health Research and Development (ZonMW; project number 446001009); the Dutch National Epilepsy Fund (EpilepsieNL) and Health Holland (project number 40‐41200‐98‐9335); and the Christelijke Vereniging voor de Verpleging van Lijders aan Epilepsie. LivAssured, the company developing the NightWatch device, has an exclusive license to use the data for commercial purposes in exchange for a percentage of the revenue directed to the University Medical Center Utrecht and Kempenhaeghe. The Dutch Tele‐Epilepsy Consortium will receive research funds if this generates profits. None of the authors has financial interests in LivAssured nor has received or will receive income from future sales of NightWatch. LivAssured and the funding sources had no role in the study design, analysis, or decision to submit for publication. ",

year = "2023",

month = aug,

doi = "10.1111/epi.17654",

language = "English",

volume = "64",

pages = "2137--2152",

journal = "Epilepsia",

issn = "0013-9580",

publisher = "Wiley-Blackwell",

number = "8",

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TY - JOUR

T1 - Multimodal nocturnal seizure detection in children with epilepsy

T2 - A prospective, multicenter, long-term, in-home trial

AU - Dutch TeleEpilepsy Consortium

AU - van Westrhenen, Anouk

AU - Lazeron, Richard H.C.

AU - van Dijk, Johannes P.

AU - Leijten, Frans S.S.

AU - Thijs, Roland D.

N1 - Funding Information: This work was supported by the Netherlands Organization for Health Research and Development (ZonMW; project number 446001009); the Dutch National Epilepsy Fund (EpilepsieNL) and Health Holland (project number 40‐41200‐98‐9335); and the Christelijke Vereniging voor de Verpleging van Lijders aan Epilepsie. LivAssured, the company developing the NightWatch device, has an exclusive license to use the data for commercial purposes in exchange for a percentage of the revenue directed to the University Medical Center Utrecht and Kempenhaeghe. The Dutch Tele‐Epilepsy Consortium will receive research funds if this generates profits. None of the authors has financial interests in LivAssured nor has received or will receive income from future sales of NightWatch. LivAssured and the funding sources had no role in the study design, analysis, or decision to submit for publication.

PY - 2023/8

Y1 - 2023/8

N2 - Objective: There 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. Methods: We 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). Results: We 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. Significance: The NightWatch system demonstrated high sensitivity for detecting nocturnal major motor seizures in children in a family home setting and reduced caregiver stress.

AB - Objective: There 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. Methods: We 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). Results: We 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. Significance: The NightWatch system demonstrated high sensitivity for detecting nocturnal major motor seizures in children in a family home setting and reduced caregiver stress.

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KW - NightWatch

KW - seizure detection device

KW - SUDEP

KW - wearable

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

Abstract

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Keywords

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