Epilepsy and SUDEP
What Changes
Heart rate rises around seizures, breathing can become shallow and heart rate slow after them, heart rate variability is often low, and sleep position is part of the risk picture.
Candidate Research Measures
Evidence
Neurology and CNS Research
See the Nights and Days Between Clinic Visits
Seizures at night, breathing that weakens lying down, a heart that no longer adapts to standing: neurological disease shows itself at home, between appointments. Hexoskin records ECG, breathing, sleep, and movement together, on one clock, with a garment worn at home, so programs measure what patients and caregivers live with.
Hexoskin Medical System (HMS): FDA 510(k) K243981 for recording, displaying, and storing 3-lead ECG, heart rate, respiratory rate, and activity in adults in non-critical settings. Pediatric programs use Hexoskin research garments under the study protocol.
Why Continuous Physiology Matters in Neurology
Neurological diseases change the autonomic nervous system, breathing, sleep, and movement, often at night and away from the clinic. Hexoskin garments record ECG, breathing from the chest and abdomen, and movement continuously in daily life and during sleep, on one clock. Research groups use them to study seizures and the cardiorespiratory changes around them, autonomic and gait changes in Parkinson’s disease and multiple system atrophy, respiratory decline in ALS, and sleep disruption. The Hexoskin Medical System is FDA-cleared for adults, and Hexoskin technology is cited in 325+ scientific publications.
Find Your Disease by What It Changes
Neurological diseases differ in cause but often share what they change in the body. Choose the domain closest to your program: it sets what to record, for how long, and at what time of day.
Candidate Research MeasureA research measure to evaluate in the program, never an endpoint.
01
Seizures and Cardiorespiratory Events
Convulsive seizures change heart rate, breathing, and movement at the same moment, and the postictal period carries risk.
Discuss This Indication
02
Movement, Gait, and Autonomic Change
Parkinson’s disease and related disorders change heart rate variability, the response to standing, gait, and sleep.
Parkinson’s Disease
What Changes
Heart rate variability falls, and orthostatic hypotension, REM sleep behavior disorder, and gait changes, including freezing of gait, appear.
Candidate Research Measures
Evidence
Multiple System Atrophy
What Changes
Orthostatic hypotension, stridor, and sleep-disordered breathing are common, and sudden death can occur during sleep.
The full card, with candidate research measures and evidence, is on the Rare Disease Research page.
Long COVID and POTS
What Changes
Heart rate rises excessively on standing, heart rate variability is low, and physical conditioning declines.
Candidate Research Measures
03
Respiratory Decline
In ALS, breathing weakens first at night.
Amyotrophic Lateral Sclerosis (ALS)
What Changes
Respiratory muscles weaken, breathing declines at night with hypoventilation, and daily activity falls.
The full card, with candidate research measures and evidence, is on the Rare Disease Research page.
04
Sleep and Circadian Disruption
Sleep continuity and rest-activity rhythm change in narcolepsy and in neurodegeneration.
Narcolepsy
What Changes
Night sleep is fragmented, with autonomic and cardiovascular changes.
Candidate Research Measures
Alzheimer’s Disease
What Changes
Sleep and circadian rhythm are disrupted, and agitation is common.
Candidate Research Measures
Evidence
How Sponsors Use Continuous Physiology
Neurology programs need measures that capture what happens at home and at night, where seizures, falls, and breathing events happen. Continuous recording adds information from each participant without adding visits.
Natural History and Progression
Describe how breathing, rhythm, sleep, and activity change over months, at home, before a trial defines what to measure.
Endpoint and Biomarker Research
Test candidate digital measures against reference methods and clinical scales, in the intended population, with a defined context of use.
Home and Hybrid Recording
Record between site visits with a garment families can put on, so travel and site burden do not limit data.
Safety Observations
Collect ECG and breathing alongside investigational treatments, for review by the study team after each recording.
Early-Phase Activity Signals
Look for exploratory physiological signals in dose-finding and proof-of-concept cohorts.
Extensions and Long-Term Follow-Up
Keep measuring for years with the same method, after the main trial ends.
Post-Approval Evidence and Registries
Add objective home measures to registries and real-world studies.
Data Science and AI
Build and validate models on traceable raw signals, with documented processing and signal quality.
For Patient Organizations and Research Networks
Patient organizations in epilepsy, ALS, Parkinson’s disease, and rare neurological disorders fund the registries and outcome research that shape trials. Hexoskin adds objective home measures beside what patients and caregivers report, with a routine people can follow at home and at night, and prepares the evidence sponsors ask for.
What a Program Gets
HMS
Hexoskin Medical System
FDA 510(k) K243981 for recording, displaying, and storing 3-lead ECG, heart rate, respiratory rate, and activity in adults in non-critical settings, and configurable for research measures.
Explore the HMSHexoskin
Hexoskin Research Garments
ECG at 256 Hz, breathing from the chest and abdomen at 128 Hz, and acceleration at 64 Hz, about 42,000 data points per minute. Breathing is measured directly, not estimated from ECG or PPG, and sleep staging is validated against polysomnography. Junior sizes support pediatric research protocols.
Explore HexoskinHexoskin OneAppHexoskin OneViewHexoskin OneAPI
Software and Data Access
Hexoskin OneApp for participants and their families to sync recordings at home, Hexoskin OneView for session review, and Hexoskin OneAPI to connect recordings to study data systems and decentralized trial platforms.
Explore the SoftwareStudy Services
Study Services
Protocol feasibility, participant and caregiver instructions, site and home logistics, staff training, and multisite coordination.
Explore Study ServicesData and AI
Data and AI Services
Signal processing, signal quality, custom algorithms, and biomarker development work on the raw signals.
Explore AI and AnalysisData Security
Secure Data Handling
Encrypted transfer, secure hosting with daily backups, and access configured for each site, user, and study role.
Explore the SoftwareHow We Work
Every program starts with a conversation about the disease and the research question, not the device.
First Conversation
Thirty minutes on the program, the population, and what matters to measure.
Working Session
Clinical, biomarker, and data teams review candidate measures, reference methods, and data flow.
Protocol Feasibility
Wear schedule, sites, participant and caregiver burden, and data transfer, checked against the draft protocol.
Agreements and Vendor Qualification
A confidentiality agreement, then the security and quality documents your vendor process needs.
Scope and Quote
Equipment, platform, services, and the analysis plan, scoped to the program’s question and quoted by phase.
Study Delivery
Equipment and logistics, site and participant support, data review, and reporting.
Evidence
Hexoskin technology is cited in 325+ scientific publications. The studies below concern neurological diseases. The full list is on the Scientific Publications page.
Nguyen, E., Robert, M., Ding, T. Y., Gharbi, O., Jahani, A., St-Jean, J., Rodriguez, C., Wabi, I. S., Lazo, D. A. G., Nguyen, D. K., & Bou Assi, E. (2025). Assessment of a biometric shirt for sleep body position identification in epilepsy. Frontiers in Neurology. https://doi.org/10.3389/fneur.2025.1662988
The Hexoskin algorithm achieved 65% prone, 75% supine, 94% right lateral decubitus, 81% left lateral decubitus, and 65% sitting/standing classification accuracy compared to VEEG. Excluding intermediate positions (336 h) resulted in 80% prone, 76% supine, and 84% left classification accuracy. Results are based on a sample of 10 patients.
St-Jean, J., Gharbi, O., Toffa, D. H., Tran, T. P. Y., Robert, M., Nguyen, D. K., & Bou Assi, E. (2025). Detection of focal impaired awareness seizures using a biometric shirt. Epilepsia Open. https://doi.org/10.1002/epi4.70099
At a firing power threshold of 0.65, the system achieved a mean sensitivity of 66% and a false alarm rate of 30.6 per 24 hours. The results include a subset of 13 out of 27 patients who demonstrated 100% event sensitivity.
Ding, T. Y., Gagliano, L., Jahani, A., Toffa, D. H., Nguyen, D. K., & Bou Assi, E. (2024). Epileptic seizure forecasting with wearable-based nocturnal sleep features. Epilepsia Open, 9(5), 1793-1805. https://doi.org/10.1002/epi4.13008
Gharbi, O., Lamrani, Y., St-Jean, J., Jahani, A., Toffa, D. H., Tran, T. P. Y., Robert, M., Nguyen, D. K., & Bou Assi, E. (2024). Detection of focal to bilateral tonic-clonic seizures using a connected shirt. Epilepsia, 65(8), 2280–2294. https://doi.org/10.1111/epi.18021
Gagliano, L., Ding, T. Y., Toffa, D. H., Beauregard, L., Robert, M., Lesage, F., Sawan, M., Nguyen, D. K., & Bou Assi, E. (2023). Decrease in wearable-based nocturnal sleep efficiency precedes epileptic seizures. Frontiers in Neurology, 13, 1089094. https://doi.org/10.3389/fneur.2022.1089094
Lamrani, Y., Tran, T. P. Y., Toffa, D. H., Robert, M., Bérubé, A. A., Nguyen, D. K., & Bou Assi, E. (2023). Unexpected cardiorespiratory findings postictally and at rest weeks prior to SUDEP. Frontiers in Neurology, 14, 1129395. https://doi.org/10.3389/fneur.2023.1129395
Hexoskin monitoring identified an unusual prolonged postictal cardiorespiratory disturbance weeks before sudden unexpected death in epilepsy in this single-patient report.
Ishii, M. (2019). Respiratory responses reflecting the emotional contribution to freezing of gait in Parkinson's disease. WPC 2019 Abstracts. https://doi.org/10.3233/jpd-199900
Banerjee, T., Peterson, M., Oliver, Q., Froehle, A., & Lawhorne, L. (2018). Validating a Commercial Device for Continuous Activity Measurement in the Older Adult Population for Dementia Management. Smart Health, 5-6, 51-62. https://doi.org/10.1016/j.smhl.2017.11.001
Measure What Happens Between Visits
Tell us the indication, the population, and the decision ahead. A Hexoskin specialist replies within two business days.