NCT05635396

Seizures Detection in Real Life Setting

A Prospective, Multicenter, Exploratory Study for Epileptic Seizures Detection Through Multimodal Analysis of Cardiorespiratory and Actimetry Parameters

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Reliev Technologies · Industry
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

Summary

Epilepsy is a disabling neurological disease that affects tens of millions of people worldwide. Despite therapeutic advances, about a third of these patients suffer from treatment-resistant forms of epilepsy and still experience regular seizures.All seizures can last and lead to status epilepticus, which is a major neurological emergency. Epilepsy can also be accompanied with cognitive or psychiatric comorbidities. Reliable seizures count is an essential indicator for estimating the care quality and for optimizing treatment. Several studies have highlighted the difficulty for patients to keep a reliable seizure diary due for example to memory loss or perception alterations during crisis. Whatever the reasons, it has been observed that at least 50% of seizures are on average missed by patients. Seizure detection has been widely developed in recent decades and are generally based on physiological signs monitoring associated with biomarkers search and coupled with detection algorithms. Multimodal approaches, i.e. combining several sensors at the same time, are considered the most promising. Mobile or wearable non invasive devices, allowing an objective seizures documentation in daily life activities, appear to be of major interest for patients and care givers, in detecting and anticipating seizures occurence. This single-arm exploratory, multicenter study aims at assessing whether the use of such a non-invasive, wearable device can be useful in a real life setting in detecting seizures occurence through multimodal analysis of various parameters (heart rate, respiratory and accelerometry).

Conditions

• Epilepsy; Seizure
• Focal Epilepsy

Interventions

Type	Name	Description
DEVICE	Wearable, non invasive sensor for seizure detection	The device consists of a chest strap and an electronics module that attaches to the strap. The device stores and transmits vital sign data including ECG, heart rate, respiration rate, body orientation and activity. This sensor will be worn every day (on a 24 hours basis) excepted during weekends for up to 4 weeks.

Timeline

• Start date: 2022-12-15
• Primary completion: 2023-03-15
• Completion: 2023-03-15
• First posted: 2022-12-02
• Last updated: 2022-12-02