Epilepsy
Conditions
Keywords
ECG, Accelerometer, Device
Brief summary
This study is designed to collect data to support development of a novel product designed to sense changes in heart rate or movement during periods of sleep in people with epilepsy. When a potential seizure is detected, the system sends out an audio-visual notification.
Detailed description
This is a prospective, interventional, un-blinded, non-significant risk, multi-site study.
Interventions
DEVICEProGuardian
The investigational system is composed of a sensor, patch, hub, and caregiver application. The sensor is applied externally during periods of nocturnal sleep for up to 7 nights. The investigational system: * is not implantable and no surgical procedure is required for a human subject to use the devices; * is not for use in supporting or sustaining a human life; and * is not of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health. * Contains skin-contacting materials made of medical grade materials (e.g. sold for use as surgical or wound care) with well-established biocompatibility testing profiles.
Sponsors
Cyberonics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following inclusion criteria: 1. Five (5) years of age or older 2. Caregiver capable of understanding and willing to comply with instructions provided in English for proper use of the study device as well as scheduled study visits. 3. Guardian/Parent for subjects less than 18 years or with cognitive limitation that would preclude consent must be willing and able to complete informed consent/and HIPAA authorization. 4. A self-reported diagnosis of epilepsy. 5. Currently taking at least one antiepileptic medication. Caregivers must meet the following inclusion criteria: 1. Eighteen (18) years of age or older 2. Capable of understanding and willing to comply with instructions provided in english for proper use of the study device as well as scheduled study visits 3. Willing and able to complete informed consent and HIPAA authorization.
Exclusion criteria
Subjects are not eligible to be enrolled in the study if they meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess product useability | Up to 7 nights/7 days | This study is designed to collect usability data from the intended use population of people with epilepsy and their caregivers to support development of a novel product designed to capture ECG signals and accelerometer data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Collect ECG and accelerometer data; device wearability; and evaluate adverse events. | Up to 7 nights/7 days | Assess ECG and accelerometer data, device adhesion and dermal response |
Countries
United States
Outcome results
None listed