RecruitingNot ApplicableNCT06275685

Forecasting Seizures Using Intelligent Wearable Technology for Health Tracking

Forecasting Seizures Using IntelliGent Wearable Technology for Health Tracking

Sponsor

Empatica, Inc.

Enrollment

3,000 participants

Start Date

Apr 11, 2024

Study Type

INTERVENTIONAL

Conditions

Epilepsy; Seizure

Summary

The goal of this interventional study is to develop a personalized seizure risk forecast tool in people with epilepsy. The main questions it aims to answer are: * can we develop a future seizure probabilities tool that is more accurate than chance based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables. * does this tool improve the lives of people with epilepsy? Researchers will compare a group that does not have access to the forecast tool to a group that does and see if it is accurate and if people with it report that it improved their quality of life.

Eligibility

Min Age: 6 Years

Inclusion Criteria5

Subjects must be diagnosed with or be at risk of epilepsy
Subjects or their parents or guardians must understand and consent to be in the study;
Subjects or their parents or guardians must be able to read and communicate in English;
Subjects or their parents or guardians must be willing and able to comply with study procedures and duration;
Subjects must have a wrist circumference suitable for wearing the EmbracePlus device.

Exclusion Criteria4

Subjects, or their parents or guardians for minor study participants, who do not understand the study and the risks;
Subjects, or their parents or guardians for minor study participants, who are either physically or cognitively incapable of performing study activities (e.g. filling in surveys and daily e-diary);
Subjects who would be placed at undue medical risk associated with any procedure called for in the protocol; or
Subjects that are Empatica employees and actively participated in the development of this protocol or development of the Seizure Wise algorithms.

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Interventions

DEVICESeizureWise algorithm

An investigational algorithm which enables forecasting of future seizure probabilities based on the pattern and frequency of previous generalized tonic-clonic seizure (GTCS) events, as well as changes in physiological and behavioral variables

DEVICEMulti-day Visualizations

Multi-day visualizations of sensor derived data